0 Bedömningar

ID

44697

Beskrivning

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

Länk

http://clinicaltrials.gov/show/NCT00247390

Nyckelord

  1. 2012-02-17 2012-02-17 -
  2. 2017-06-06 2017-06-06 - Martin Dugas
  3. 2021-09-27 2021-09-27 -
Uppladdad den

27 september 2021

DOI

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Licens

Creative Commons BY 4.0

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    Long-Term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Einschlusskriterien
    Beskrivning

    Einschlusskriterien

    Alias
    UMLS CUI-1
    C1512693
    Alter 18 Jahre und älter
    Beskrivning

    legal adult

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1706450
    Females of childbearing potential who are sexually active must agree to use adequate contraception
    Beskrivning

    contraception

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0700589
    Females of childbearing potential can neither be pregnant nor lactating from Screening throughout the duration of the study
    Beskrivning

    not pregnant and not lactating

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0232973
    UMLS CUI [1,2]
    C2826207
    Body mass index between 18 and 34, inclusive
    Beskrivning

    Body mass index

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1305855
    Based on sleep history, has had chronic insomnia for at least 3 months
    Beskrivning

    chronic insomnia

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0751249
    Based on sleep history, reports a subjective sleep latency greater than or equal to 45 min
    Beskrivning

    sleep latency

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0430629
    Based on sleep history, reports a subjective total sleep time less than or equal to 6.5 hours
    Beskrivning

    total sleep time

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1822180
    Based on sleep history, habitual bedtime is between 10:00 PM and 1:00 AM
    Beskrivning

    habitual bedtime

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2135946
    Mean latency to persistent sleep of greater than 20 minutes on two consecutive screening nights with neither night less than 15 minutes
    Beskrivning

    Mean latency to persistent sleep

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0430629
    A mean of 60 minutes of wake time during the 480 minutes in bed across two nights with no night less than 45 minutes
    Beskrivning

    wake time

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0442696
    UMLS CUI [1,2]
    C1948053
    Based on sleep history, normally uses pharmacological assistance to sleep 0 to 4 times per week in the last 3 months
    Beskrivning

    taking medication to help sleep

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2054158
    Ausschlusskriterien
    Beskrivning

    Ausschlusskriterien

    Alias
    UMLS CUI-1
    C0680251
    Known hypersensitivity to ramelteon or related compounds, including melatonin, and melatonin related compounds
    Beskrivning

    hypersensitivity to ramelteon

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C1565316
    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
    Beskrivning

    other study

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    Sleep schedule changes required by employment (eg, shift worker) within three months prior to the administration of single-blind study medication
    Beskrivning

    recent change in sleep by employment

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2133559
    UMLS CUI [1,2]
    C0578815
    Flown across greater than three time zones within 7 days prior to or during screening
    Beskrivning

    recent long airplane flight

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2169581
    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
    Beskrivning

    weight loss program or altered exercise routine

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3179079
    UMLS CUI [1,2]
    C0740930
    Has ever had a history of seizures, sleep apnea, restless leg syndrome, periodic leg movement syndrome, chronic obstructive pulmonary disease or fibromyalgia
    Beskrivning

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

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0036572
    UMLS CUI [1,3]
    C0037315
    UMLS CUI [1,4]
    C0035258
    UMLS CUI [1,5]
    C0024117
    UMLS CUI [1,6]
    C0016053
    History of psychiatric disorder within the past 6 months
    Beskrivning

    History of psychiatric disorder

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0455498
    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
    Beskrivning

    History of alcohol abuse

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0221628
    History of drug abuse within the past 12 months, as defined in Diagnostic & Statistical Manual of Mental Disorders, 4th Edition Revised
    Beskrivning

    History of drug abuse

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1299544
    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
    Beskrivning

    Significant disease

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0973444
    Apnea hypopnea index (per hour of sleep) greater than 10 as seen on the first polysomnogram screening night
    Beskrivning

    Apnea Hypopnea Index

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2111846
    Periodic Leg Movement Syndrome with arousal index (per hour of sleep) greater than 10 as seen on the first polysomnogram screening night
    Beskrivning

    Periodic Leg Movement Syndrome with arousal index

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C4062601
    UMLS CUI [1,2]
    C4050457
    Positive urine drug screen at Screening Visit 1 or any of the polysomnogram assessment visits
    Beskrivning

    Positive urine drug screen

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0743300
    Positive breathalyzer test on any of the polysomnogram assessment visits
    Beskrivning

    Positive breathalyzer test

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0085924
    UMLS CUI [1,2]
    C1446409
    Uses tobacco products (including nicotine gum and patch) or any other products that may interfere with the sleep wake cycle during nightly awakenings
    Beskrivning

    tobacco use

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0543414
    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.
    Beskrivning

    central nervous system medication

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0007680
    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
    Beskrivning

    Patient Non-Compliance

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0376405
    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:
    Beskrivning

    Non-compliance

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0457432
    Anxiolytics
    Beskrivning

    Anxiolytics

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0040616
    Sedatives
    Beskrivning

    Sedatives

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0036557
    Hypnotics
    Beskrivning

    Hypnotics

    Datatyp

    boolean

    CNS active drugs (including herbal)
    Beskrivning

    CNS active drugs

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0007680
    Antidepressants
    Beskrivning

    Antidepressants

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0003289
    Narcotic analgesics
    Beskrivning

    Narcotic analgesics

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0027409
    Anticonvulsants
    Beskrivning

    Anticonvulsants

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0003286
    Beta blockers
    Beskrivning

    Beta blockers

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0304516
    Sedating H1 antihistamines
    Beskrivning

    Sedating antihistamine

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1955826
    St. John's Wort
    Beskrivning

    Hypericum perforatum

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0936242
    Systemic steroids
    Beskrivning

    Systemic steroids

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2825233
    Kava-kava
    Beskrivning

    Kava kava

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0939882
    Respiratory stimulants
    Beskrivning

    Respiratory stimulants

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0282685
    Ginkgo-biloba
    Beskrivning

    Ginkgo biloba

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0330206
    Decongestants
    Beskrivning

    Decongestants

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0282374
    Over-the-counter and prescription stimulants
    Beskrivning

    Stimulant

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0304402
    Antipsychotics
    Beskrivning

    Antipsychotics

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0040615
    Over-the-counter and prescription diet aids
    Beskrivning

    Diet Aid

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0719894
    Muscle Relaxants
    Beskrivning

    Muscle Relaxants

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0358430
    Melatonin and all other drugs or supplements known to affect sleep/wake function
    Beskrivning

    Melatonin

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0025219
    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
    Beskrivning

    Unsuitable for other reasons

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3844399
    History of hepatitis B or hepatitis C
    Beskrivning

    History of hepatitis B or hepatitis C

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1997078
    UMLS CUI [1,2]
    C4040623

    Similar models

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Einschlusskriterien
    C1512693 (UMLS CUI-1)
    legal adult
    Item
    Alter 18 Jahre und älter
    boolean
    C1706450 (UMLS CUI [1,1])
    contraception
    Item
    Females of childbearing potential who are sexually active must agree to use adequate contraception
    boolean
    C0700589 (UMLS CUI [1])
    not pregnant and not lactating
    Item
    Females of childbearing potential can neither be pregnant nor lactating from Screening throughout the duration of the study
    boolean
    C0232973 (UMLS CUI [1,1])
    C2826207 (UMLS CUI [1,2])
    Body mass index
    Item
    Body mass index between 18 and 34, inclusive
    boolean
    C1305855 (UMLS CUI [1])
    chronic insomnia
    Item
    Based on sleep history, has had chronic insomnia for at least 3 months
    boolean
    C0751249 (UMLS CUI [1])
    sleep latency
    Item
    Based on sleep history, reports a subjective sleep latency greater than or equal to 45 min
    boolean
    C0430629 (UMLS CUI [1])
    total sleep time
    Item
    Based on sleep history, reports a subjective total sleep time less than or equal to 6.5 hours
    boolean
    C1822180 (UMLS CUI [1])
    habitual bedtime
    Item
    Based on sleep history, habitual bedtime is between 10:00 PM and 1:00 AM
    boolean
    C2135946 (UMLS CUI [1])
    Mean latency to persistent sleep
    Item
    Mean latency to persistent sleep of greater than 20 minutes on two consecutive screening nights with neither night less than 15 minutes
    boolean
    C0430629 (UMLS CUI [1])
    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
    C0442696 (UMLS CUI [1,1])
    C1948053 (UMLS CUI [1,2])
    taking medication to help sleep
    Item
    Based on sleep history, normally uses pharmacological assistance to sleep 0 to 4 times per week in the last 3 months
    boolean
    C2054158 (UMLS CUI [1])
    Item Group
    Ausschlusskriterien
    C0680251 (UMLS CUI-1)
    hypersensitivity to ramelteon
    Item
    Known hypersensitivity to ramelteon or related compounds, including melatonin, and melatonin related compounds
    boolean
    C0020517 (UMLS CUI [1,1])
    C1565316 (UMLS CUI [1,2])
    other study
    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
    C2348568 (UMLS CUI [1])
    recent change in sleep 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
    C2133559 (UMLS CUI [1,1])
    C0578815 (UMLS CUI [1,2])
    recent long airplane flight
    Item
    Flown across greater than three time zones within 7 days prior to or during screening
    boolean
    C2169581 (UMLS CUI [1])
    weight loss program or altered 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
    C3179079 (UMLS CUI [1,1])
    C0740930 (UMLS CUI [1,2])
    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
    C0262926 (UMLS CUI [1,1])
    C0036572 (UMLS CUI [1,2])
    C0037315 (UMLS CUI [1,3])
    C0035258 (UMLS CUI [1,4])
    C0024117 (UMLS CUI [1,5])
    C0016053 (UMLS CUI [1,6])
    History of psychiatric disorder
    Item
    History of psychiatric disorder within the past 6 months
    boolean
    C0455498 (UMLS CUI [1])
    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
    C0221628 (UMLS CUI [1])
    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
    C1299544 (UMLS CUI [1])
    Significant 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
    C0973444 (UMLS CUI [1])
    Apnea Hypopnea Index
    Item
    Apnea hypopnea index (per hour of sleep) greater than 10 as seen on the first polysomnogram screening night
    boolean
    C2111846 (UMLS CUI [1])
    Periodic Leg Movement Syndrome with arousal index
    Item
    Periodic Leg Movement Syndrome with arousal index (per hour of sleep) greater than 10 as seen on the first polysomnogram screening night
    boolean
    C4062601 (UMLS CUI [1,1])
    C4050457 (UMLS CUI [1,2])
    Positive urine drug screen
    Item
    Positive urine drug screen at Screening Visit 1 or any of the polysomnogram assessment visits
    boolean
    C0743300 (UMLS CUI [1])
    Positive breathalyzer test
    Item
    Positive breathalyzer test on any of the polysomnogram assessment visits
    boolean
    C0085924 (UMLS CUI [1,1])
    C1446409 (UMLS CUI [1,2])
    tobacco use
    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
    C0543414 (UMLS CUI [1])
    central nervous system medication
    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
    C0007680 (UMLS CUI [1])
    Patient Non-Compliance
    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
    C0376405 (UMLS CUI [1])
    Non-compliance
    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
    C0457432 (UMLS CUI [1])
    Anxiolytics
    Item
    Anxiolytics
    boolean
    C0040616 (UMLS CUI [1])
    Sedatives
    Item
    Sedatives
    boolean
    C0036557 (UMLS CUI [1])
    Hypnotics
    Item
    Hypnotics
    boolean
    CNS active drugs
    Item
    CNS active drugs (including herbal)
    boolean
    C0007680 (UMLS CUI [1])
    Antidepressants
    Item
    Antidepressants
    boolean
    C0003289 (UMLS CUI [1])
    Narcotic analgesics
    Item
    Narcotic analgesics
    boolean
    C0027409 (UMLS CUI [1])
    Anticonvulsants
    Item
    Anticonvulsants
    boolean
    C0003286 (UMLS CUI [1])
    Beta blockers
    Item
    Beta blockers
    boolean
    C0304516 (UMLS CUI [1])
    Sedating antihistamine
    Item
    Sedating H1 antihistamines
    boolean
    C1955826 (UMLS CUI [1])
    Hypericum perforatum
    Item
    St. John's Wort
    boolean
    C0936242 (UMLS CUI [1])
    Systemic steroids
    Item
    Systemic steroids
    boolean
    C2825233 (UMLS CUI [1])
    Kava kava
    Item
    Kava-kava
    boolean
    C0939882 (UMLS CUI [1])
    Respiratory stimulants
    Item
    Respiratory stimulants
    boolean
    C0282685 (UMLS CUI [1])
    Ginkgo biloba
    Item
    Ginkgo-biloba
    boolean
    C0330206 (UMLS CUI [1])
    Decongestants
    Item
    Decongestants
    boolean
    C0282374 (UMLS CUI [1])
    Stimulant
    Item
    Over-the-counter and prescription stimulants
    boolean
    C0304402 (UMLS CUI [1])
    Antipsychotics
    Item
    Antipsychotics
    boolean
    C0040615 (UMLS CUI [1])
    Diet Aid
    Item
    Over-the-counter and prescription diet aids
    boolean
    C0719894 (UMLS CUI [1])
    Muscle Relaxants
    Item
    Muscle Relaxants
    boolean
    C0358430 (UMLS CUI [1])
    Melatonin
    Item
    Melatonin and all other drugs or supplements known to affect sleep/wake function
    boolean
    C0025219 (UMLS CUI [1])
    Unsuitable for other reasons
    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
    C3844399 (UMLS CUI [1])
    History of hepatitis B or hepatitis C
    Item
    History of hepatitis B or hepatitis C
    boolean
    C1997078 (UMLS CUI [1,1])
    C4040623 (UMLS CUI [1,2])

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