ID

44697

Description

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

Link

http://clinicaltrials.gov/show/NCT00247390

Keywords

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

September 27, 2021

DOI

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License

Creative Commons BY 4.0
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Long-Term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Age 18 years and older
Description

legal adult

Data type

boolean

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

contraception

Data type

boolean

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

not pregnant and not lactating

Data type

boolean

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

Body mass index

Data type

boolean

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

chronic insomnia

Data type

boolean

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

sleep latency

Data type

boolean

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

total sleep time

Data type

boolean

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

habitual bedtime

Data type

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
Description

Mean latency to persistent sleep

Data type

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
Description

wake time

Data type

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
Description

taking medication to help sleep

Data type

boolean

Alias
UMLS CUI [1]
C2054158
Exclusion Criteria
Description

Exclusion Criteria

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

hypersensitivity to ramelteon

Data type

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
Description

other study

Data type

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
Description

recent change in sleep by employment

Data type

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
Description

recent long airplane flight

Data type

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
Description

weight loss program or altered exercise routine

Data type

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
Description

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

Data type

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
Description

History of psychiatric disorder

Data type

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
Description

History of alcohol abuse

Data type

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
Description

History of drug abuse

Data type

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
Description

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

Data type

boolean

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

Apnea Hypopnea Index

Data type

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
Description

Periodic Leg Movement Syndrome with arousal index

Data type

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
Description

Positive urine drug screen

Data type

boolean

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

Positive breathalyzer test

Data type

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
Description

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

Data type

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.
Description

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

Data type

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
Description

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

Data type

boolean

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:
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0457432
Anxiolytics
Description

Anxiolytics

Data type

boolean

Alias
UMLS CUI [1]
C0040616
Sedatives
Description

Sedatives

Data type

boolean

Alias
UMLS CUI [1]
C0036557
Hypnotics
Description

Hypnotics

Data type

boolean

CNS active drugs (including herbal)
Description

CNS active drugs

Data type

boolean

Alias
UMLS CUI [1]
C0007680
Antidepressants
Description

Antidepressants

Data type

boolean

Alias
UMLS CUI [1]
C0003289
Narcotic analgesics
Description

Narcotic analgesics

Data type

boolean

Alias
UMLS CUI [1]
C0027409
Anticonvulsants
Description

Anticonvulsants

Data type

boolean

Alias
UMLS CUI [1]
C0003286
Beta blockers
Description

Beta blockers

Data type

boolean

Alias
UMLS CUI [1]
C0304516
Sedating H1 antihistamines
Description

Sedating antihistamine

Data type

boolean

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

Hypericum perforatum

Data type

boolean

Alias
UMLS CUI [1]
C0936242
Systemic steroids
Description

Systemic steroids

Data type

boolean

Alias
UMLS CUI [1]
C2825233
Kava-kava
Description

Kava kava

Data type

boolean

Alias
UMLS CUI [1]
C0939882
Respiratory stimulants
Description

Respiratory stimulants

Data type

boolean

Alias
UMLS CUI [1]
C0282685
Ginkgo-biloba
Description

Ginkgo biloba

Data type

boolean

Alias
UMLS CUI [1]
C0330206
Decongestants
Description

Decongestants

Data type

boolean

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

Stimulant

Data type

boolean

Alias
UMLS CUI [1]
C0304402
Antipsychotics
Description

Antipsychotics

Data type

boolean

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

Diet Aid

Data type

boolean

Alias
UMLS CUI [1]
C0719894
Muscle Relaxants
Description

Muscle Relaxants

Data type

boolean

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

Melatonin

Data type

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
Description

Unsuitable for other reasons

Data type

boolean

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

History of hepatitis B or hepatitis C

Data type

boolean

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

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
legal adult
Item
Age 18 years and older
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
Exclusion Criteria
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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