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ID
185
Description
ODM derived from http://clinicaltrials.gov/show/NCT00247390
Link
http://clinicaltrials.gov/show/NCT00247390
Keywords
Versions (3)
- 2/17/12 2/17/12 -
- 6/6/17 6/6/17 - Martin Dugas
- 9/27/21 9/27/21 -
Uploaded on
February 17, 2012
DOI
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License
Creative Commons BY-NC 3.0
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Eligibility NCT00247390 Chronic Insomnia
Similar models
Eligibility
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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
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
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
102518004 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnosis
string
Contraception
Item
Contraception
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Lactation
Item
Breast feeding, Nursing
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
10006247 (MedDRA 13.1)
pregnant
Item
pregnant
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
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)
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)
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)
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)
418634005 (SNOMED CT 2010_0731)
T78.40 (ICD-10-CM Version 2010)
Ramelteon
Item
Ramelteon (substance)
string
Melatonin
Item
Melatonin (substance)
string
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
Nicotine gum
Item
Nicotine chewing gum
string
C0068722 (UMLS CUI)
346593007 (SNOMED CT 2010_0731)
346593007 (SNOMED CT 2010_0731)
Nicotine patch
Item
Nicotine m/r transdermal patch
string
C0358855 (UMLS CUI)
346594001 (SNOMED CT 2010_0731)
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)
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)
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)
373282008 (SNOMED CT 2010_0731)
Sedative
Item
Sedative (substance)
string
C0036557 (UMLS CUI)
372614000 (SNOMED CT 2010_0731)
372614000 (SNOMED CT 2010_0731)
Hypnotics
Item
Hypnotic agent
string
Antidepressants
Item
Antidepressive Agents
string
Analgesics, Narcotic
Item
Narcotic analgesic product
string
C0027409 (UMLS CUI)
360204007 (SNOMED CT 2010_0731)
360204007 (SNOMED CT 2010_0731)
Antiepileptic Agents
Item
Anticonvulsant (substance)
string
Beta Blocker
Item
Adrenergic beta-Antagonists
string
Histamine H1 Antagonists
Item
H1 antihistamine (substance)
string
C0019592 (UMLS CUI)
373228009 (SNOMED CT 2010_0731)
373228009 (SNOMED CT 2010_0731)
Hypericum perforatum
Item
St. John's Wort
string
C0936242 (UMLS CUI)
51621002 (SNOMED CT 2010_0731)
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)
Z79.52 (ICD-10-CM Version 2010)
Kava preparation
Item
Kava kava
string
C0939882 (UMLS CUI)
412231002 (SNOMED CT 2010_0731)
412231002 (SNOMED CT 2010_0731)
Stimulants, Respiratory
Item
Respiratory stimulant (substance)
string
C0282685 (UMLS CUI)
418760000 (SNOMED CT 2010_0731)
418760000 (SNOMED CT 2010_0731)
Ginkgo biloba
Item
Ginkgo biloba extract
string
C0772125 (UMLS CUI)
412394005 (SNOMED CT 2010_0731)
412394005 (SNOMED CT 2010_0731)
Decongestants
Item
Decongestant preparation
string
C0282374 (UMLS CUI)
96328007 (SNOMED CT 2010_0731)
96328007 (SNOMED CT 2010_0731)
Stimulant
Item
Stimulant (substance)
string
Prescriptions
Item
Prescription (procedure)
string
C0033080 (UMLS CUI)
16076005 (SNOMED CT 2010_0731)
16076005 (SNOMED CT 2010_0731)
Antipsychotic Agent
Item
Antipsychotic agent (substance)
string
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)
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)
50711007 (SNOMED CT 2010_0731)
10019744 (MedDRA 13.1)
B19.20 (ICD-10-CM Version 2010)
070.7 (ICD-9-CM Version 2011)