ID

185

Beschrijving

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

Link

http://clinicaltrials.gov/show/NCT00247390

Trefwoorden

  1. 17-02-12 17-02-12 -
  2. 06-06-17 06-06-17 - Martin Dugas
  3. 27-09-21 27-09-21 -
Geüploaded op

17 februari 2012

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0

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Eligibility NCT00247390 Chronic Insomnia

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Beschrijving

Einschlusskriterien

Alter 18 Jahre und älter
Beschrijving

Age

Datatype

boolean

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

Females of childbearing potential must agree to use adequate contraception

Datatype

boolean

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

Females of childbearing potential can neither be pregnant nor lactating

Datatype

boolean

Body mass index between 18 and 34, inclusive
Beschrijving

Body mass index between 18 and 34

Datatype

boolean

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

chronic insomnia

Datatype

boolean

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

subjective sleep latency greater than or equal to 45 min

Datatype

boolean

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

subjective total sleep time less than or equal to 6.5 hours

Datatype

boolean

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

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

Datatype

boolean

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

Mean latency to persistent sleep of greater than 20 minutes

Datatype

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
Beschrijving

a mean of 60 minutes of wake time

Datatype

boolean

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

pharmacological assistance to sleep 0 to 4 times per week

Datatype

boolean

Ausschlusskriterien
Beschrijving

Ausschlusskriterien

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

hypersensitivity to ramelteon or related compounds

Datatype

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
Beschrijving

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

Datatype

boolean

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

Sleep schedule changes required by employment

Datatype

boolean

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

Flown across greater than three time zones

Datatype

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
Beschrijving

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

Datatype

boolean

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

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

Datatype

boolean

History of psychiatric disorder within the past 6 months
Beschrijving

History of psychiatric disorder

Datatype

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
Beschrijving

History of alcohol abuse

Datatype

boolean

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

History of drug abuse

Datatype

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
Beschrijving

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

Datatype

boolean

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

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

Datatype

boolean

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

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

Datatype

boolean

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

Positive urine drug screen

Datatype

boolean

Positive breathalyzer test on any of the polysomnogram assessment visits
Beschrijving

Positive breathalyzer test

Datatype

boolean

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

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

Datatype

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.
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

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:
Beschrijving

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

Datatype

boolean

Anxiolytics
Beschrijving

Anxiolytics

Datatype

boolean

Sedatives
Beschrijving

Sedatives

Datatype

boolean

Hypnotics
Beschrijving

Hypnotics

Datatype

boolean

CNS active drugs (including herbal)
Beschrijving

CNS active drugs (including herbal)

Datatype

boolean

Antidepressants
Beschrijving

Antidepressants

Datatype

boolean

Narcotic analgesics
Beschrijving

Narcotic analgesics

Datatype

boolean

Anticonvulsants
Beschrijving

Anticonvulsants

Datatype

boolean

Beta blockers
Beschrijving

Beta blockers

Datatype

boolean

Sedating H1 antihistamines
Beschrijving

Sedating H1 antihistamines

Datatype

boolean

St. John's Wort
Beschrijving

St. John's Wort

Datatype

boolean

Systemic steroids
Beschrijving

Systemic steroids

Datatype

boolean

Kava-kava
Beschrijving

Kava-kava

Datatype

boolean

Respiratory stimulants
Beschrijving

Respiratory stimulants

Datatype

boolean

Ginkgo-biloba
Beschrijving

Ginkgo-biloba

Datatype

boolean

Decongestants
Beschrijving

Decongestants

Datatype

boolean

Over-the-counter and prescription stimulants
Beschrijving

Over-the-counter and prescription stimulants

Datatype

boolean

Antipsychotics
Beschrijving

Antipsychotics

Datatype

boolean

Over-the-counter and prescription diet aids
Beschrijving

Over-the-counter and prescription diet aids

Datatype

boolean

Muscle Relaxants
Beschrijving

Muscle Relaxants

Datatype

boolean

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

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

Datatype

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
Beschrijving

additional condition(s)

Datatype

boolean

History of hepatitis B or hepatitis C
Beschrijving

History of hepatitis B or hepatitis C

Datatype

boolean

Medizinische Konzepte
Beschrijving

Medizinische Konzepte

Alter
Beschrijving

Age

Datatype

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Diagnose
Beschrijving

Diagnosis

Datatype

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Kontrazeption
Beschrijving

Contraception

Datatype

string

Alias
UMLS CUI
C0700589
SNOMED CT 2010_0731
146680009
MedDRA 13.1
10010808
Stillzeit
Beschrijving

Lactation

Datatype

string

Alias
UMLS CUI
C0006147
MedDRA 13.1
10006247
schwanger
Beschrijving

pregnant

Datatype

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
BMI
Beschrijving

BMI

Datatype

string

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

Chronic Insomnia

Datatype

string

Alias
UMLS CUI
C0751249
MedDRA 13.1
10053851
Reduced sleep latency
Beschrijving

Reduced sleep latency

Datatype

string

Alias
UMLS CUI
C2674747
Bedtime
Beschrijving

Hour of sleep

Datatype

string

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

Hypersensitivity

Datatype

string

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

Ramelteon

Datatype

string

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

Melatonin

Datatype

string

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

Blinded clinical study

Datatype

string

Alias
UMLS CUI
C0681870
Medikation
Beschrijving

Pharmaceutical Preparations

Datatype

string

Alias
UMLS CUI
C0013227
Time zone
Beschrijving

Time zone

Datatype

string

Alias
UMLS CUI
C2825194
Screening
Beschrijving

Screening

Datatype

string

Alias
UMLS CUI
C1409616
Weight loss advised
Beschrijving

Weight loss advised

Datatype

string

Alias
UMLS CUI
C0555962
SNOMED CT 2010_0731
275919002
Convulsion
Beschrijving

Seizures

Datatype

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
Beschrijving

Sleep apnea syndromes

Datatype

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
Beschrijving

Restless legs syndrome

Datatype

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
Beschrijving

Periodic leg movements of sleep

Datatype

string

Alias
UMLS CUI
C2919187
SNOMED CT 2010_0731
445140006
COPD
Beschrijving

COPD

Datatype

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
Beschrijving

Fibromyalgia

Datatype

string

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

Mental disorders

Datatype

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
Alkohol-Abusus
Beschrijving

Alcohol abuse

Datatype

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
Beschrijving

Drug abuse

Datatype

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
Beschrijving

Liver disorder

Datatype

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
Beschrijving

Renal disease

Datatype

string

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

Endocrine system diseases

Datatype

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
Beschrijving

Cardiovascular diseases

Datatype

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
Beschrijving

Gastrointestinal diseases

Datatype

string

Alias
UMLS CUI
C0017178
SNOMED CT 2010_0731
119292006
MedDRA 13.1
10017944
Lungenerkrankung
Beschrijving

Pulmonary disease

Datatype

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
Beschrijving

Hematological disease

Datatype

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
Beschrijving

Nervous system disorder

Datatype

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
Beschrijving

Metabolic disorder

Datatype

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)
Beschrijving

Nocturnal myoclonus syndrome

Datatype

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
Beschrijving

Urine drug screen positive

Datatype

string

Alias
UMLS CUI
C0743300
MedDRA 13.1
10051105
Polysomnogram
Beschrijving

Polysomnography

Datatype

string

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

Breathalyzer test

Datatype

string

Alias
UMLS CUI
C0085924
SNOMED CT 2010_0731
D001944
positive
Beschrijving

positive

Datatype

string

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

Use of tobacco products at least daily

Datatype

string

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

Nicotine gum

Datatype

string

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

Nicotine patch

Datatype

string

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

Organic disorder of sleep wake cycle

Datatype

string

Alias
UMLS CUI
C1561880
Central nervous system agents
Beschrijving

CNS agents

Datatype

string

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

Single blind study

Datatype

string

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

Misuse of over-the-counter medications

Datatype

string

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

Herbal drugs

Datatype

string

Alias
UMLS CUI
C1360419
Anxiolytic Agents
Beschrijving

Anti-Anxiety Agents

Datatype

string

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

Sedative

Datatype

string

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

Hypnotics

Datatype

string

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

Antidepressants

Datatype

string

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

Analgesics, Narcotic

Datatype

string

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

Antiepileptic Agents

Datatype

string

Alias
UMLS CUI
C0003299
SNOMED CT 2010_0731
255632006
LOINC Version 232
MTHU006781
Beta-Blocker
Beschrijving

Beta Blocker

Datatype

string

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

Histamine H1 Antagonists

Datatype

string

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

Hypericum perforatum

Datatype

string

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

systemic steroids

Datatype

string

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

Kava preparation

Datatype

string

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

Stimulants, Respiratory

Datatype

string

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

Ginkgo biloba

Datatype

string

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

Decongestants

Datatype

string

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

Stimulant

Datatype

string

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

Prescriptions

Datatype

string

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

Antipsychotic Agent

Datatype

string

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

Diet Aid

Datatype

string

Alias
UMLS CUI
C0719894
Muscle relaxants
Beschrijving

Muscle relaxants

Datatype

string

Alias
UMLS CUI
C0358430
Type B viral hepatitis
Beschrijving

Hepatitis B

Datatype

string

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

Hepatitis C

Datatype

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)
Datatype
Alias
Item Group
Einschlusskriterien
Age
Item
Alter 18 Jahre und älter
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
Ausschlusskriterien
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
Medizinische Konzepte
Age
Item
Alter
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnose
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Contraception
Item
Kontrazeption
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Lactation
Item
Stillzeit
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
pregnant
Item
schwanger
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
BMI
Item
BMI
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
Medikation
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
COPD
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
Alkohol-Abusus
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
Lungenerkrankung
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
Beta-Blocker
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)

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