0 Ratings

ID

185

Description

ODM derived from http://clinicaltrials.gov/show/NCT00247390

Link

http://clinicaltrials.gov/show/NCT00247390

Keywords

  1. 2/17/12 2/17/12 -
  2. 6/6/17 6/6/17 - Martin Dugas
  3. 9/27/21 9/27/21 -
Uploaded on

February 17, 2012

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :


    No comments

    In order to download data models you must be logged in. Please log in or register for free.

    Eligibility NCT00247390 Chronic Insomnia

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Inclusion Criteria
    Description

    Inclusion Criteria

    Age 18 years and older
    Description

    Age

    Data type

    boolean

    Females of childbearing potential who are sexually active must agree to use adequate contraception
    Description

    Females of childbearing potential must agree to use adequate contraception

    Data type

    boolean

    Females of childbearing potential can neither be pregnant nor lactating from Screening throughout the duration of the study
    Description

    Females of childbearing potential can neither be pregnant nor lactating

    Data type

    boolean

    Body mass index between 18 and 34, inclusive
    Description

    Body mass index between 18 and 34

    Data type

    boolean

    Based on sleep history, has had chronic insomnia for at least 3 months
    Description

    chronic insomnia

    Data type

    boolean

    Based on sleep history, reports a subjective sleep latency greater than or equal to 45 min
    Description

    subjective sleep latency greater than or equal to 45 min

    Data type

    boolean

    Based on sleep history, reports a subjective total sleep time less than or equal to 6.5 hours
    Description

    subjective total sleep time less than or equal to 6.5 hours

    Data type

    boolean

    Based on sleep history, habitual bedtime is between 10:00 PM and 1:00 AM
    Description

    habitual bedtime between 10:00 PM and 1:00 AM

    Data type

    boolean

    Mean latency to persistent sleep of greater than 20 minutes on two consecutive screening nights with neither night less than 15 minutes
    Description

    Mean latency to persistent sleep of greater than 20 minutes

    Data type

    boolean

    A mean of 60 minutes of wake time during the 480 minutes in bed across two nights with no night less than 45 minutes
    Description

    a mean of 60 minutes of wake time

    Data type

    boolean

    Based on sleep history, normally uses pharmacological assistance to sleep 0 to 4 times per week in the last 3 months
    Description

    pharmacological assistance to sleep 0 to 4 times per week

    Data type

    boolean

    Exclusion Criteria
    Description

    Exclusion Criteria

    Known hypersensitivity to ramelteon or related compounds, including melatonin, and melatonin related compounds
    Description

    hypersensitivity to ramelteon or related compounds

    Data type

    boolean

    Participated in any other investigational study and/or taken any investigational drug within 30 days or five half-lives prior to the first dose of single-blind study medication, whichever is longer
    Description

    Participated in any other investigational study and/or taken any investigational drug

    Data type

    boolean

    Sleep schedule changes required by employment (eg, shift worker) within three months prior to the administration of single-blind study medication
    Description

    Sleep schedule changes required by employment

    Data type

    boolean

    Flown across greater than three time zones within 7 days prior to or during screening
    Description

    Flown across greater than three time zones

    Data type

    boolean

    Participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the administration of single-blind study medication
    Description

    Participated in a weight loss program or has substantially altered their exercise routine

    Data type

    boolean

    Has ever had a history of seizures, sleep apnea, restless leg syndrome, periodic leg movement syndrome, chronic obstructive pulmonary disease or fibromyalgia
    Description

    history of seizures, sleep apnea, restless leg syndrome, periodic leg movement syndrome, chronic obstructive pulmonary disease or fibromyalgia

    Data type

    boolean

    History of psychiatric disorder within the past 6 months
    Description

    History of psychiatric disorder

    Data type

    boolean

    History of alcohol abuse within the past 12 months, as defined in Diagnostic & Statistical Manual of Mental Disorders, 4th Edition Revised, or regularly consumes more than 14 alcoholic drinks per week, or consumed any alcoholic drinks within 24 hours of any polysomnogram visits
    Description

    History of alcohol abuse

    Data type

    boolean

    History of drug abuse within the past 12 months, as defined in Diagnostic & Statistical Manual of Mental Disorders, 4th Edition Revised
    Description

    History of drug abuse

    Data type

    boolean

    Current significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, neurological, or metabolic disease, unless currently controlled and stable with protocol-allowed medication, within 30 days prior to the first night of single-blind study medication
    Description

    Current significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, neurological, or metabolic disease

    Data type

    boolean

    Apnea hypopnea index (per hour of sleep) greater than 10 as seen on the first polysomnogram screening night
    Description

    Apnea hypopnea index (per hour of sleep) greater than 10

    Data type

    boolean

    Periodic Leg Movement Syndrome with arousal index (per hour of sleep) greater than 10 as seen on the first polysomnogram screening night
    Description

    Periodic Leg Movement Syndrome with arousal index (per hour of sleep) greater than 10

    Data type

    boolean

    Positive urine drug screen at Screening Visit 1 or any of the polysomnogram assessment visits
    Description

    Positive urine drug screen

    Data type

    boolean

    Positive breathalyzer test on any of the polysomnogram assessment visits
    Description

    Positive breathalyzer test

    Data type

    boolean

    Uses tobacco products (including nicotine gum and patch) or any other products that may interfere with the sleep wake cycle during nightly awakenings
    Description

    Uses tobacco products or any other products that may interfere with the sleep wake cycle

    Data type

    boolean

    Used any central nervous system medication or other drugs or supplements known to affect sleep/wake function within 1 week (or 5 half lives of the drug, whichever is longer) prior to the administration of single-blind study medication. These medications must not have been used to treat psychiatric disorders.
    Description

    Used any central nervous system medication or other drugs or supplements known to affect sleep/wake function

    Data type

    boolean

    Intends to continue taking any disallowed medication or any prescription medication or over the counter medication that is known to affect the sleep/wake function or otherwise interfere with evaluation of the study medication. The subject must report all prescription and over the counter medications taken in the three weeks prior to screening
    Description

    Intends to continue taking any disallowed medication or any prescription medication or over the counter medication that is known to affect the sleep/wake function

    Data type

    boolean

    Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
    Description

    taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication

    Data type

    boolean

    Anxiolytics
    Description

    Anxiolytics

    Data type

    boolean

    Sedatives
    Description

    Sedatives

    Data type

    boolean

    Hypnotics
    Description

    Hypnotics

    Data type

    boolean

    CNS active drugs (including herbal)
    Description

    CNS active drugs (including herbal)

    Data type

    boolean

    Antidepressants
    Description

    Antidepressants

    Data type

    boolean

    Narcotic analgesics
    Description

    Narcotic analgesics

    Data type

    boolean

    Anticonvulsants
    Description

    Anticonvulsants

    Data type

    boolean

    Beta blockers
    Description

    Beta blockers

    Data type

    boolean

    Sedating H1 antihistamines
    Description

    Sedating H1 antihistamines

    Data type

    boolean

    St. John's Wort
    Description

    St. John's Wort

    Data type

    boolean

    Systemic steroids
    Description

    Systemic steroids

    Data type

    boolean

    Kava-kava
    Description

    Kava-kava

    Data type

    boolean

    Respiratory stimulants
    Description

    Respiratory stimulants

    Data type

    boolean

    Ginkgo-biloba
    Description

    Ginkgo-biloba

    Data type

    boolean

    Decongestants
    Description

    Decongestants

    Data type

    boolean

    Over-the-counter and prescription stimulants
    Description

    Over-the-counter and prescription stimulants

    Data type

    boolean

    Antipsychotics
    Description

    Antipsychotics

    Data type

    boolean

    Over-the-counter and prescription diet aids
    Description

    Over-the-counter and prescription diet aids

    Data type

    boolean

    Muscle Relaxants
    Description

    Muscle Relaxants

    Data type

    boolean

    Melatonin and all other drugs or supplements known to affect sleep/wake function
    Description

    Melatonin and all other drugs or supplements known to affect sleep/wake function

    Data type

    boolean

    Any additional condition(s) that in the Investigator's opinion would affect sleep/wake function, prohibit the subject from completing the study, indicate that continuation in the study would not be in the best interests of the subject
    Description

    additional condition(s)

    Data type

    boolean

    History of hepatitis B or hepatitis C
    Description

    History of hepatitis B or hepatitis C

    Data type

    boolean

    Medical Concepts
    Description

    Medical Concepts

    Age
    Description

    Age

    Data type

    string

    Alias
    UMLS CUI
    C0001779
    SNOMED CT 2010_0731
    102518004
    Diagnosis
    Description

    Diagnosis

    Data type

    string

    Alias
    UMLS CUI
    C0011900
    SNOMED CT 2010_0731
    439401001
    LOINC Version 232
    MTHU008876
    Contraception
    Description

    Contraception

    Data type

    string

    Alias
    UMLS CUI
    C0700589
    SNOMED CT 2010_0731
    146680009
    MedDRA 13.1
    10010808
    Breast feeding, Nursing
    Description

    Lactation

    Data type

    string

    Alias
    UMLS CUI
    C0006147
    MedDRA 13.1
    10006247
    pregnant
    Description

    pregnant

    Data type

    string

    Alias
    UMLS CUI
    C0549206
    MedDRA 13.1
    10036586
    Body mass index
    Description

    BMI

    Data type

    string

    Alias
    UMLS CUI
    C1305855
    SNOMED CT 2010_0731
    140075008
    MedDRA 13.1
    10005894
    LOINC Version 232
    LP35925-4
    Chronic Insomnia
    Description

    Chronic Insomnia

    Data type

    string

    Alias
    UMLS CUI
    C0751249
    MedDRA 13.1
    10053851
    Reduced sleep latency
    Description

    Reduced sleep latency

    Data type

    string

    Alias
    UMLS CUI
    C2674747
    Bedtime
    Description

    Hour of sleep

    Data type

    string

    Alias
    UMLS CUI
    C0521112
    SNOMED CT 2010_0731
    21029003
    Allergic reaction to substance
    Description

    Hypersensitivity

    Data type

    string

    Alias
    UMLS CUI
    C0020517
    SNOMED CT 2010_0731
    418634005
    ICD-10-CM Version 2010
    T78.40
    Ramelteon (substance)
    Description

    Ramelteon

    Data type

    string

    Alias
    UMLS CUI
    C1565316
    SNOMED CT 2010_0731
    419878007
    LOINC Version 232
    MTHU035868
    Melatonin (substance)
    Description

    Melatonin

    Data type

    string

    Alias
    UMLS CUI
    C0025219
    SNOMED CT 2010_0731
    41199001
    LOINC Version 232
    MTHU002350
    Blind study
    Description

    Blinded clinical study

    Data type

    string

    Alias
    UMLS CUI
    C0681870
    Medication
    Description

    Pharmaceutical Preparations

    Data type

    string

    Alias
    UMLS CUI
    C0013227
    Time zone
    Description

    Time zone

    Data type

    string

    Alias
    UMLS CUI
    C2825194
    Screening
    Description

    Screening

    Data type

    string

    Alias
    UMLS CUI
    C1409616
    Weight loss advised
    Description

    Weight loss advised

    Data type

    string

    Alias
    UMLS CUI
    C0555962
    SNOMED CT 2010_0731
    275919002
    Convulsion
    Description

    Seizures

    Data type

    string

    Alias
    UMLS CUI
    C0036572
    SNOMED CT 2010_0731
    91175000
    MedDRA 13.1
    10039910
    ICD-9-CM Version 2011
    780.39
    SAS - Sleep apnea syndrome
    Description

    Sleep apnea syndromes

    Data type

    string

    Alias
    UMLS CUI
    C0037315
    SNOMED CT 2010_0731
    73430006
    MedDRA 13.1
    10040979
    ICD-10-CM Version 2010
    G47.30
    ICD-9-CM Version 2011
    780.57
    CTCAE Version 4.03
    E13566
    Restless legs syndrome
    Description

    Restless legs syndrome

    Data type

    string

    Alias
    UMLS CUI
    C0035258
    SNOMED CT 2010_0731
    32914008
    MedDRA 13.1
    10058920
    ICD-10-CM Version 2010
    G25.81
    ICD-9-CM Version 2011
    333.94
    Periodic leg movements of sleep
    Description

    Periodic leg movements of sleep

    Data type

    string

    Alias
    UMLS CUI
    C2919187
    SNOMED CT 2010_0731
    445140006
    Chronic Obstructive Pulmonary Disease
    Description

    COPD

    Data type

    string

    Alias
    UMLS CUI
    C0024117
    SNOMED CT 2010_0731
    13645005
    MedDRA 13.1
    10009033
    ICD-10-CM Version 2010
    J44.9
    ICD-9-CM Version 2011
    496
    Fibromyalgia
    Description

    Fibromyalgia

    Data type

    string

    Alias
    UMLS CUI
    C0016053
    SNOMED CT 2010_0731
    24693007
    MedDRA 13.1
    10048439
    ICD-10-CM Version 2010
    M79.7
    Psychiatric disorder
    Description

    Mental disorders

    Data type

    string

    Alias
    UMLS CUI
    C0004936
    SNOMED CT 2010_0731
    74732009
    MedDRA 13.1
    10037174
    ICD-10-CM Version 2010
    F99
    ICD-9-CM Version 2011
    290-319.99
    Alcohol abuse
    Description

    Alcohol abuse

    Data type

    string

    Alias
    UMLS CUI
    C0085762
    SNOMED CT 2010_0731
    15167005
    MedDRA 13.1
    10001584
    LOINC Version 232
    LP36309-0
    ICD-10-CM Version 2010
    F10.1
    ICD-9-CM Version 2011
    305.0
    Drug abuse
    Description

    Drug abuse

    Data type

    string

    Alias
    UMLS CUI
    C0013146
    SNOMED CT 2010_0731
    26416006
    MedDRA 13.1
    10013654
    LOINC Version 232
    LP36310-8
    ICD-9-CM Version 2011
    305.90
    Liver diseases
    Description

    Liver disorder

    Data type

    string

    Alias
    UMLS CUI
    C0023895
    SNOMED CT 2010_0731
    235856003
    MedDRA 13.1
    10024670
    ICD-10-CM Version 2010
    K76.9
    ICD-9-CM Version 2011
    573.9
    Kidney Diseases
    Description

    Renal disease

    Data type

    string

    Alias
    UMLS CUI
    C0022658
    SNOMED CT 2010_0731
    90708001
    MedDRA 13.1
    10029151
    ICD-10-CM Version 2010
    N18.9
    Endocrine system diseases
    Description

    Endocrine system diseases

    Data type

    string

    Alias
    UMLS CUI
    C0014130
    SNOMED CT 2010_0731
    362969004
    MedDRA 13.1
    10014695
    LOINC Version 232
    MTHU021570
    ICD-10-CM Version 2010
    E34.9
    ICD-9-CM Version 2011
    259.9
    Disease affecting entire cardiovascular system
    Description

    Cardiovascular diseases

    Data type

    string

    Alias
    UMLS CUI
    C0007222
    SNOMED CT 2010_0731
    105980002
    MedDRA 13.1
    10007649
    ICD-9-CM Version 2011
    429.2
    Disorder of gastrointestinal tract
    Description

    Gastrointestinal diseases

    Data type

    string

    Alias
    UMLS CUI
    C0017178
    SNOMED CT 2010_0731
    119292006
    MedDRA 13.1
    10017944
    Lung diseases
    Description

    Pulmonary disease

    Data type

    string

    Alias
    UMLS CUI
    C0024115
    SNOMED CT 2010_0731
    19829001
    MedDRA 13.1
    10025082
    ICD-10-CM Version 2010
    J98.4
    Diseases of blood and bloodforming organs
    Description

    Hematological disease

    Data type

    string

    Alias
    UMLS CUI
    C0018939
    SNOMED CT 2010_0731
    191124002
    MedDRA 13.1
    10061590
    ICD-10-CM Version 2010
    D75.9
    ICD-9-CM Version 2011
    289.9
    Neurological disorder
    Description

    Nervous system disorder

    Data type

    string

    Alias
    UMLS CUI
    C0027765
    SNOMED CT 2010_0731
    118940003
    MedDRA 13.1
    10029202
    ICD-10-CM Version 2010
    G98.8
    ICD-9-CM Version 2011
    349.9
    MD - metabolic disorders
    Description

    Metabolic disorder

    Data type

    string

    Alias
    UMLS CUI
    C0025517
    SNOMED CT 2010_0731
    30390004
    MedDRA 13.1
    10058097
    ICD-10-CM Version 2010
    E88.9
    ICD-9-CM Version 2011
    277.9
    Periodic limb movement disorder (PLMD)
    Description

    Nocturnal myoclonus syndrome

    Data type

    string

    Alias
    UMLS CUI
    C0751774
    SNOMED CT 2010_0731
    418763003
    MedDRA 13.1
    10064600
    ICD-10-CM Version 2010
    G47.61
    ICD-9-CM Version 2011
    327.51
    Urine drug screen positive
    Description

    Urine drug screen positive

    Data type

    string

    Alias
    UMLS CUI
    C0743300
    MedDRA 13.1
    10051105
    Polysomnogram
    Description

    Polysomnography

    Data type

    string

    Alias
    UMLS CUI
    C0162701
    SNOMED CT 2010_0731
    60554003
    MedDRA 13.1
    10053319
    ICD-9-CM Version 2011
    89.17
    Breathalyzer test
    Description

    Breathalyzer test

    Data type

    string

    Alias
    UMLS CUI
    C0085924
    SNOMED CT 2010_0731
    D001944
    positive
    Description

    positive

    Data type

    string

    Alias
    UMLS CUI
    CL415097
    Use of tobacco products at least daily
    Description

    Use of tobacco products at least daily

    Data type

    string

    Alias
    UMLS CUI
    C1976668
    LOINC Version 232
    MTHU026131
    Nicotine chewing gum
    Description

    Nicotine gum

    Data type

    string

    Alias
    UMLS CUI
    C0068722
    SNOMED CT 2010_0731
    346593007
    Nicotine m/r transdermal patch
    Description

    Nicotine patch

    Data type

    string

    Alias
    UMLS CUI
    C0358855
    SNOMED CT 2010_0731
    346594001
    Organic disorder of sleep wake cycle
    Description

    Organic disorder of sleep wake cycle

    Data type

    string

    Alias
    UMLS CUI
    C1561880
    Central nervous system agents
    Description

    CNS agents

    Data type

    string

    Alias
    UMLS CUI
    C0007680
    SNOMED CT 2010_0731
    372752008
    Single-blind study
    Description

    Single blind study

    Data type

    string

    Alias
    UMLS CUI
    C0242570
    Misuse of over-the-counter medications
    Description

    Misuse of over-the-counter medications

    Data type

    string

    Alias
    UMLS CUI
    C1827845
    SNOMED CT 2010_0731
    424626006
    Herbal drugs
    Description

    Herbal drugs

    Data type

    string

    Alias
    UMLS CUI
    C1360419
    Anxiolytic Agents
    Description

    Anti-Anxiety Agents

    Data type

    string

    Alias
    UMLS CUI
    C0040616
    SNOMED CT 2010_0731
    373282008
    Sedative (substance)
    Description

    Sedative

    Data type

    string

    Alias
    UMLS CUI
    C0036557
    SNOMED CT 2010_0731
    372614000
    Hypnotic agent
    Description

    Hypnotics

    Data type

    string

    Alias
    UMLS CUI
    C0020591
    SNOMED CT 2010_0731
    372585002
    LOINC Version 232
    MTHU015316
    Antidepressive Agents
    Description

    Antidepressants

    Data type

    string

    Alias
    UMLS CUI
    C0003289
    SNOMED CT 2010_0731
    372720008
    LOINC Version 232
    MTHU006782
    Narcotic analgesic product
    Description

    Analgesics, Narcotic

    Data type

    string

    Alias
    UMLS CUI
    C0027409
    SNOMED CT 2010_0731
    360204007
    Anticonvulsant (substance)
    Description

    Antiepileptic Agents

    Data type

    string

    Alias
    UMLS CUI
    C0003299
    SNOMED CT 2010_0731
    255632006
    LOINC Version 232
    MTHU006781
    Adrenergic beta-Antagonists
    Description

    Beta Blocker

    Data type

    string

    Alias
    UMLS CUI
    C0001645
    SNOMED CT 2010_0731
    33252009
    LOINC Version 232
    MTHU003324
    H1 antihistamine (substance)
    Description

    Histamine H1 Antagonists

    Data type

    string

    Alias
    UMLS CUI
    C0019592
    SNOMED CT 2010_0731
    373228009
    St. John's Wort
    Description

    Hypericum perforatum

    Data type

    string

    Alias
    UMLS CUI
    C0936242
    SNOMED CT 2010_0731
    51621002
    Long term (current) use of systemic steroids
    Description

    systemic steroids

    Data type

    string

    Alias
    UMLS CUI
    C2911187
    ICD-10-CM Version 2010
    Z79.52
    Kava kava
    Description

    Kava preparation

    Data type

    string

    Alias
    UMLS CUI
    C0939882
    SNOMED CT 2010_0731
    412231002
    Respiratory stimulant (substance)
    Description

    Stimulants, Respiratory

    Data type

    string

    Alias
    UMLS CUI
    C0282685
    SNOMED CT 2010_0731
    418760000
    Ginkgo biloba extract
    Description

    Ginkgo biloba

    Data type

    string

    Alias
    UMLS CUI
    C0772125
    SNOMED CT 2010_0731
    412394005
    Decongestant preparation
    Description

    Decongestants

    Data type

    string

    Alias
    UMLS CUI
    C0282374
    SNOMED CT 2010_0731
    96328007
    Stimulant (substance)
    Description

    Stimulant

    Data type

    string

    Alias
    UMLS CUI
    C0304402
    SNOMED CT 2010_0731
    373333006
    LOINC Version 232
    MTHU003469
    Prescription (procedure)
    Description

    Prescriptions

    Data type

    string

    Alias
    UMLS CUI
    C0033080
    SNOMED CT 2010_0731
    16076005
    Antipsychotic agent (substance)
    Description

    Antipsychotic Agent

    Data type

    string

    Alias
    UMLS CUI
    C0040615
    SNOMED CT 2010_0731
    372482001
    LOINC Version 232
    MTHU003337
    Diet Aid
    Description

    Diet Aid

    Data type

    string

    Alias
    UMLS CUI
    C0719894
    Muscle relaxants
    Description

    Muscle relaxants

    Data type

    string

    Alias
    UMLS CUI
    C0358430
    Type B viral hepatitis
    Description

    Hepatitis B

    Data type

    string

    Alias
    UMLS CUI
    C0019163
    SNOMED CT 2010_0731
    66071002
    MedDRA 13.1
    10019731
    Viral hepatitis C
    Description

    Hepatitis C

    Data type

    string

    Alias
    UMLS CUI
    C0019196
    SNOMED CT 2010_0731
    50711007
    MedDRA 13.1
    10019744
    ICD-10-CM Version 2010
    B19.20
    ICD-9-CM Version 2011
    070.7

    Similar models

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Inclusion Criteria
    Age
    Item
    Age 18 years and older
    boolean
    Females of childbearing potential must agree to use adequate contraception
    Item
    Females of childbearing potential who are sexually active must agree to use adequate contraception
    boolean
    Females of childbearing potential can neither be pregnant nor lactating
    Item
    Females of childbearing potential can neither be pregnant nor lactating from Screening throughout the duration of the study
    boolean
    Body mass index between 18 and 34
    Item
    Body mass index between 18 and 34, inclusive
    boolean
    chronic insomnia
    Item
    Based on sleep history, has had chronic insomnia for at least 3 months
    boolean
    subjective sleep latency greater than or equal to 45 min
    Item
    Based on sleep history, reports a subjective sleep latency greater than or equal to 45 min
    boolean
    subjective total sleep time less than or equal to 6.5 hours
    Item
    Based on sleep history, reports a subjective total sleep time less than or equal to 6.5 hours
    boolean
    habitual bedtime between 10:00 PM and 1:00 AM
    Item
    Based on sleep history, habitual bedtime is between 10:00 PM and 1:00 AM
    boolean
    Mean latency to persistent sleep of greater than 20 minutes
    Item
    Mean latency to persistent sleep of greater than 20 minutes on two consecutive screening nights with neither night less than 15 minutes
    boolean
    a mean of 60 minutes of wake time
    Item
    A mean of 60 minutes of wake time during the 480 minutes in bed across two nights with no night less than 45 minutes
    boolean
    pharmacological assistance to sleep 0 to 4 times per week
    Item
    Based on sleep history, normally uses pharmacological assistance to sleep 0 to 4 times per week in the last 3 months
    boolean
    Item Group
    Exclusion Criteria
    hypersensitivity to ramelteon or related compounds
    Item
    Known hypersensitivity to ramelteon or related compounds, including melatonin, and melatonin related compounds
    boolean
    Participated in any other investigational study and/or taken any investigational drug
    Item
    Participated in any other investigational study and/or taken any investigational drug within 30 days or five half-lives prior to the first dose of single-blind study medication, whichever is longer
    boolean
    Sleep schedule changes required by employment
    Item
    Sleep schedule changes required by employment (eg, shift worker) within three months prior to the administration of single-blind study medication
    boolean
    Flown across greater than three time zones
    Item
    Flown across greater than three time zones within 7 days prior to or during screening
    boolean
    Participated in a weight loss program or has substantially altered their exercise routine
    Item
    Participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the administration of single-blind study medication
    boolean
    history of seizures, sleep apnea, restless leg syndrome, periodic leg movement syndrome, chronic obstructive pulmonary disease or fibromyalgia
    Item
    Has ever had a history of seizures, sleep apnea, restless leg syndrome, periodic leg movement syndrome, chronic obstructive pulmonary disease or fibromyalgia
    boolean
    History of psychiatric disorder
    Item
    History of psychiatric disorder within the past 6 months
    boolean
    History of alcohol abuse
    Item
    History of alcohol abuse within the past 12 months, as defined in Diagnostic & Statistical Manual of Mental Disorders, 4th Edition Revised, or regularly consumes more than 14 alcoholic drinks per week, or consumed any alcoholic drinks within 24 hours of any polysomnogram visits
    boolean
    History of drug abuse
    Item
    History of drug abuse within the past 12 months, as defined in Diagnostic & Statistical Manual of Mental Disorders, 4th Edition Revised
    boolean
    Current significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, neurological, or metabolic disease
    Item
    Current significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, neurological, or metabolic disease, unless currently controlled and stable with protocol-allowed medication, within 30 days prior to the first night of single-blind study medication
    boolean
    Apnea hypopnea index (per hour of sleep) greater than 10
    Item
    Apnea hypopnea index (per hour of sleep) greater than 10 as seen on the first polysomnogram screening night
    boolean
    Periodic Leg Movement Syndrome with arousal index (per hour of sleep) greater than 10
    Item
    Periodic Leg Movement Syndrome with arousal index (per hour of sleep) greater than 10 as seen on the first polysomnogram screening night
    boolean
    Positive urine drug screen
    Item
    Positive urine drug screen at Screening Visit 1 or any of the polysomnogram assessment visits
    boolean
    Positive breathalyzer test
    Item
    Positive breathalyzer test on any of the polysomnogram assessment visits
    boolean
    Uses tobacco products or any other products that may interfere with the sleep wake cycle
    Item
    Uses tobacco products (including nicotine gum and patch) or any other products that may interfere with the sleep wake cycle during nightly awakenings
    boolean
    Used any central nervous system medication or other drugs or supplements known to affect sleep/wake function
    Item
    Used any central nervous system medication or other drugs or supplements known to affect sleep/wake function within 1 week (or 5 half lives of the drug, whichever is longer) prior to the administration of single-blind study medication. These medications must not have been used to treat psychiatric disorders.
    boolean
    Intends to continue taking any disallowed medication or any prescription medication or over the counter medication that is known to affect the sleep/wake function
    Item
    Intends to continue taking any disallowed medication or any prescription medication or over the counter medication that is known to affect the sleep/wake function or otherwise interfere with evaluation of the study medication. The subject must report all prescription and over the counter medications taken in the three weeks prior to screening
    boolean
    taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication
    Item
    Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
    boolean
    Anxiolytics
    Item
    Anxiolytics
    boolean
    Sedatives
    Item
    Sedatives
    boolean
    Hypnotics
    Item
    Hypnotics
    boolean
    CNS active drugs (including herbal)
    Item
    CNS active drugs (including herbal)
    boolean
    Antidepressants
    Item
    Antidepressants
    boolean
    Narcotic analgesics
    Item
    Narcotic analgesics
    boolean
    Anticonvulsants
    Item
    Anticonvulsants
    boolean
    Beta blockers
    Item
    Beta blockers
    boolean
    Sedating H1 antihistamines
    Item
    Sedating H1 antihistamines
    boolean
    St. John's Wort
    Item
    St. John's Wort
    boolean
    Systemic steroids
    Item
    Systemic steroids
    boolean
    Kava-kava
    Item
    Kava-kava
    boolean
    Respiratory stimulants
    Item
    Respiratory stimulants
    boolean
    Ginkgo-biloba
    Item
    Ginkgo-biloba
    boolean
    Decongestants
    Item
    Decongestants
    boolean
    Over-the-counter and prescription stimulants
    Item
    Over-the-counter and prescription stimulants
    boolean
    Antipsychotics
    Item
    Antipsychotics
    boolean
    Over-the-counter and prescription diet aids
    Item
    Over-the-counter and prescription diet aids
    boolean
    Muscle Relaxants
    Item
    Muscle Relaxants
    boolean
    Melatonin and all other drugs or supplements known to affect sleep/wake function
    Item
    Melatonin and all other drugs or supplements known to affect sleep/wake function
    boolean
    additional condition(s)
    Item
    Any additional condition(s) that in the Investigator's opinion would affect sleep/wake function, prohibit the subject from completing the study, indicate that continuation in the study would not be in the best interests of the subject
    boolean
    History of hepatitis B or hepatitis C
    Item
    History of hepatitis B or hepatitis C
    boolean
    Item Group
    Medical Concepts
    Age
    Item
    Age
    string
    C0001779 (UMLS CUI)
    102518004 (SNOMED CT 2010_0731)
    Diagnosis
    Item
    Diagnosis
    string
    C0011900 (UMLS CUI)
    439401001 (SNOMED CT 2010_0731)
    MTHU008876 (LOINC Version 232)
    Contraception
    Item
    Contraception
    string
    C0700589 (UMLS CUI)
    146680009 (SNOMED CT 2010_0731)
    10010808 (MedDRA 13.1)
    Lactation
    Item
    Breast feeding, Nursing
    string
    C0006147 (UMLS CUI)
    10006247 (MedDRA 13.1)
    pregnant
    Item
    pregnant
    string
    C0549206 (UMLS CUI)
    10036586 (MedDRA 13.1)
    BMI
    Item
    Body mass index
    string
    C1305855 (UMLS CUI)
    140075008 (SNOMED CT 2010_0731)
    10005894 (MedDRA 13.1)
    LP35925-4 (LOINC Version 232)
    Chronic Insomnia
    Item
    Chronic Insomnia
    string
    C0751249 (UMLS CUI)
    10053851 (MedDRA 13.1)
    Reduced sleep latency
    Item
    Reduced sleep latency
    string
    C2674747 (UMLS CUI)
    Hour of sleep
    Item
    Bedtime
    string
    C0521112 (UMLS CUI)
    21029003 (SNOMED CT 2010_0731)
    Hypersensitivity
    Item
    Allergic reaction to substance
    string
    C0020517 (UMLS CUI)
    418634005 (SNOMED CT 2010_0731)
    T78.40 (ICD-10-CM Version 2010)
    Ramelteon
    Item
    Ramelteon (substance)
    string
    C1565316 (UMLS CUI)
    419878007 (SNOMED CT 2010_0731)
    MTHU035868 (LOINC Version 232)
    Melatonin
    Item
    Melatonin (substance)
    string
    C0025219 (UMLS CUI)
    41199001 (SNOMED CT 2010_0731)
    MTHU002350 (LOINC Version 232)
    Blinded clinical study
    Item
    Blind study
    string
    C0681870 (UMLS CUI)
    Pharmaceutical Preparations
    Item
    Medication
    string
    C0013227 (UMLS CUI)
    Time zone
    Item
    Time zone
    string
    C2825194 (UMLS CUI)
    Screening
    Item
    Screening
    string
    C1409616 (UMLS CUI)
    Weight loss advised
    Item
    Weight loss advised
    string
    C0555962 (UMLS CUI)
    275919002 (SNOMED CT 2010_0731)
    Seizures
    Item
    Convulsion
    string
    C0036572 (UMLS CUI)
    91175000 (SNOMED CT 2010_0731)
    10039910 (MedDRA 13.1)
    780.39 (ICD-9-CM Version 2011)
    Sleep apnea syndromes
    Item
    SAS - Sleep apnea syndrome
    string
    C0037315 (UMLS CUI)
    73430006 (SNOMED CT 2010_0731)
    10040979 (MedDRA 13.1)
    G47.30 (ICD-10-CM Version 2010)
    780.57 (ICD-9-CM Version 2011)
    E13566 (CTCAE Version 4.03)
    Restless legs syndrome
    Item
    Restless legs syndrome
    string
    C0035258 (UMLS CUI)
    32914008 (SNOMED CT 2010_0731)
    10058920 (MedDRA 13.1)
    G25.81 (ICD-10-CM Version 2010)
    333.94 (ICD-9-CM Version 2011)
    Periodic leg movements of sleep
    Item
    Periodic leg movements of sleep
    string
    C2919187 (UMLS CUI)
    445140006 (SNOMED CT 2010_0731)
    COPD
    Item
    Chronic Obstructive Pulmonary Disease
    string
    C0024117 (UMLS CUI)
    13645005 (SNOMED CT 2010_0731)
    10009033 (MedDRA 13.1)
    J44.9 (ICD-10-CM Version 2010)
    496 (ICD-9-CM Version 2011)
    Fibromyalgia
    Item
    Fibromyalgia
    string
    C0016053 (UMLS CUI)
    24693007 (SNOMED CT 2010_0731)
    10048439 (MedDRA 13.1)
    M79.7 (ICD-10-CM Version 2010)
    Mental disorders
    Item
    Psychiatric disorder
    string
    C0004936 (UMLS CUI)
    74732009 (SNOMED CT 2010_0731)
    10037174 (MedDRA 13.1)
    F99 (ICD-10-CM Version 2010)
    290-319.99 (ICD-9-CM Version 2011)
    Alcohol abuse
    Item
    Alcohol abuse
    string
    C0085762 (UMLS CUI)
    15167005 (SNOMED CT 2010_0731)
    10001584 (MedDRA 13.1)
    LP36309-0 (LOINC Version 232)
    F10.1 (ICD-10-CM Version 2010)
    305.0 (ICD-9-CM Version 2011)
    Drug abuse
    Item
    Drug abuse
    string
    C0013146 (UMLS CUI)
    26416006 (SNOMED CT 2010_0731)
    10013654 (MedDRA 13.1)
    LP36310-8 (LOINC Version 232)
    305.90 (ICD-9-CM Version 2011)
    Liver disorder
    Item
    Liver diseases
    string
    C0023895 (UMLS CUI)
    235856003 (SNOMED CT 2010_0731)
    10024670 (MedDRA 13.1)
    K76.9 (ICD-10-CM Version 2010)
    573.9 (ICD-9-CM Version 2011)
    Renal disease
    Item
    Kidney Diseases
    string
    C0022658 (UMLS CUI)
    90708001 (SNOMED CT 2010_0731)
    10029151 (MedDRA 13.1)
    N18.9 (ICD-10-CM Version 2010)
    Endocrine system diseases
    Item
    Endocrine system diseases
    string
    C0014130 (UMLS CUI)
    362969004 (SNOMED CT 2010_0731)
    10014695 (MedDRA 13.1)
    MTHU021570 (LOINC Version 232)
    E34.9 (ICD-10-CM Version 2010)
    259.9 (ICD-9-CM Version 2011)
    Cardiovascular diseases
    Item
    Disease affecting entire cardiovascular system
    string
    C0007222 (UMLS CUI)
    105980002 (SNOMED CT 2010_0731)
    10007649 (MedDRA 13.1)
    429.2 (ICD-9-CM Version 2011)
    Gastrointestinal diseases
    Item
    Disorder of gastrointestinal tract
    string
    C0017178 (UMLS CUI)
    119292006 (SNOMED CT 2010_0731)
    10017944 (MedDRA 13.1)
    Pulmonary disease
    Item
    Lung diseases
    string
    C0024115 (UMLS CUI)
    19829001 (SNOMED CT 2010_0731)
    10025082 (MedDRA 13.1)
    J98.4 (ICD-10-CM Version 2010)
    Hematological disease
    Item
    Diseases of blood and bloodforming organs
    string
    C0018939 (UMLS CUI)
    191124002 (SNOMED CT 2010_0731)
    10061590 (MedDRA 13.1)
    D75.9 (ICD-10-CM Version 2010)
    289.9 (ICD-9-CM Version 2011)
    Nervous system disorder
    Item
    Neurological disorder
    string
    C0027765 (UMLS CUI)
    118940003 (SNOMED CT 2010_0731)
    10029202 (MedDRA 13.1)
    G98.8 (ICD-10-CM Version 2010)
    349.9 (ICD-9-CM Version 2011)
    Metabolic disorder
    Item
    MD - metabolic disorders
    string
    C0025517 (UMLS CUI)
    30390004 (SNOMED CT 2010_0731)
    10058097 (MedDRA 13.1)
    E88.9 (ICD-10-CM Version 2010)
    277.9 (ICD-9-CM Version 2011)
    Nocturnal myoclonus syndrome
    Item
    Periodic limb movement disorder (PLMD)
    string
    C0751774 (UMLS CUI)
    418763003 (SNOMED CT 2010_0731)
    10064600 (MedDRA 13.1)
    G47.61 (ICD-10-CM Version 2010)
    327.51 (ICD-9-CM Version 2011)
    Urine drug screen positive
    Item
    Urine drug screen positive
    string
    C0743300 (UMLS CUI)
    10051105 (MedDRA 13.1)
    Polysomnography
    Item
    Polysomnogram
    string
    C0162701 (UMLS CUI)
    60554003 (SNOMED CT 2010_0731)
    10053319 (MedDRA 13.1)
    89.17 (ICD-9-CM Version 2011)
    Breathalyzer test
    Item
    Breathalyzer test
    string
    C0085924 (UMLS CUI)
    D001944 (SNOMED CT 2010_0731)
    positive
    Item
    positive
    string
    CL415097 (UMLS CUI)
    Use of tobacco products at least daily
    Item
    Use of tobacco products at least daily
    string
    C1976668 (UMLS CUI)
    MTHU026131 (LOINC Version 232)
    Nicotine gum
    Item
    Nicotine chewing gum
    string
    C0068722 (UMLS CUI)
    346593007 (SNOMED CT 2010_0731)
    Nicotine patch
    Item
    Nicotine m/r transdermal patch
    string
    C0358855 (UMLS CUI)
    346594001 (SNOMED CT 2010_0731)
    Organic disorder of sleep wake cycle
    Item
    Organic disorder of sleep wake cycle
    string
    C1561880 (UMLS CUI)
    CNS agents
    Item
    Central nervous system agents
    string
    C0007680 (UMLS CUI)
    372752008 (SNOMED CT 2010_0731)
    Single blind study
    Item
    Single-blind study
    string
    C0242570 (UMLS CUI)
    Misuse of over-the-counter medications
    Item
    Misuse of over-the-counter medications
    string
    C1827845 (UMLS CUI)
    424626006 (SNOMED CT 2010_0731)
    Herbal drugs
    Item
    Herbal drugs
    string
    C1360419 (UMLS CUI)
    Anti-Anxiety Agents
    Item
    Anxiolytic Agents
    string
    C0040616 (UMLS CUI)
    373282008 (SNOMED CT 2010_0731)
    Sedative
    Item
    Sedative (substance)
    string
    C0036557 (UMLS CUI)
    372614000 (SNOMED CT 2010_0731)
    Hypnotics
    Item
    Hypnotic agent
    string
    C0020591 (UMLS CUI)
    372585002 (SNOMED CT 2010_0731)
    MTHU015316 (LOINC Version 232)
    Antidepressants
    Item
    Antidepressive Agents
    string
    C0003289 (UMLS CUI)
    372720008 (SNOMED CT 2010_0731)
    MTHU006782 (LOINC Version 232)
    Analgesics, Narcotic
    Item
    Narcotic analgesic product
    string
    C0027409 (UMLS CUI)
    360204007 (SNOMED CT 2010_0731)
    Antiepileptic Agents
    Item
    Anticonvulsant (substance)
    string
    C0003299 (UMLS CUI)
    255632006 (SNOMED CT 2010_0731)
    MTHU006781 (LOINC Version 232)
    Beta Blocker
    Item
    Adrenergic beta-Antagonists
    string
    C0001645 (UMLS CUI)
    33252009 (SNOMED CT 2010_0731)
    MTHU003324 (LOINC Version 232)
    Histamine H1 Antagonists
    Item
    H1 antihistamine (substance)
    string
    C0019592 (UMLS CUI)
    373228009 (SNOMED CT 2010_0731)
    Hypericum perforatum
    Item
    St. John's Wort
    string
    C0936242 (UMLS CUI)
    51621002 (SNOMED CT 2010_0731)
    systemic steroids
    Item
    Long term (current) use of systemic steroids
    string
    C2911187 (UMLS CUI)
    Z79.52 (ICD-10-CM Version 2010)
    Kava preparation
    Item
    Kava kava
    string
    C0939882 (UMLS CUI)
    412231002 (SNOMED CT 2010_0731)
    Stimulants, Respiratory
    Item
    Respiratory stimulant (substance)
    string
    C0282685 (UMLS CUI)
    418760000 (SNOMED CT 2010_0731)
    Ginkgo biloba
    Item
    Ginkgo biloba extract
    string
    C0772125 (UMLS CUI)
    412394005 (SNOMED CT 2010_0731)
    Decongestants
    Item
    Decongestant preparation
    string
    C0282374 (UMLS CUI)
    96328007 (SNOMED CT 2010_0731)
    Stimulant
    Item
    Stimulant (substance)
    string
    C0304402 (UMLS CUI)
    373333006 (SNOMED CT 2010_0731)
    MTHU003469 (LOINC Version 232)
    Prescriptions
    Item
    Prescription (procedure)
    string
    C0033080 (UMLS CUI)
    16076005 (SNOMED CT 2010_0731)
    Antipsychotic Agent
    Item
    Antipsychotic agent (substance)
    string
    C0040615 (UMLS CUI)
    372482001 (SNOMED CT 2010_0731)
    MTHU003337 (LOINC Version 232)
    Diet Aid
    Item
    Diet Aid
    string
    C0719894 (UMLS CUI)
    Muscle relaxants
    Item
    Muscle relaxants
    string
    C0358430 (UMLS CUI)
    Hepatitis B
    Item
    Type B viral hepatitis
    string
    C0019163 (UMLS CUI)
    66071002 (SNOMED CT 2010_0731)
    10019731 (MedDRA 13.1)
    Hepatitis C
    Item
    Viral hepatitis C
    string
    C0019196 (UMLS CUI)
    50711007 (SNOMED CT 2010_0731)
    10019744 (MedDRA 13.1)
    B19.20 (ICD-10-CM Version 2010)
    070.7 (ICD-9-CM Version 2011)

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial