ID

185

Beskrivning

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

Länk

http://clinicaltrials.gov/show/NCT00247390

Nyckelord

Klinische Studie [Dokumenttyp]

Eligibility Determination

D012893

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17 februari 2012

DOI

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Creative Commons BY-NC 3.0

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Eligibility NCT00247390 Chronic Insomnia

model
Detaljer

Eligibility

1 Formulär

StudyEvent: Eligibility
1. Eligibility

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Inclusion Criteria

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

Exclusion Criteria

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

Medical Concepts

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)

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Modellkommentarer :

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Eligibility NCT00247390 Chronic Insomnia

Eligibility

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