Description:

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

Link:

http://clinicaltrials.gov/show/NCT00247390

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  1. 2/17/12
  2. 6/6/17
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June 6, 2017

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Creative Commons BY-NC 3.0
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Long-Term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Age 18 years and older
Females of childbearing potential who are sexually active must agree to use adequate contraception
Females of childbearing potential can neither be pregnant nor lactating from Screening throughout the duration of the study
Body mass index between 18 and 34, inclusive
Based on sleep history, has had chronic insomnia for at least 3 months
Based on sleep history, reports a subjective sleep latency greater than or equal to 45 min
Based on sleep history, reports a subjective total sleep time less than or equal to 6.5 hours
Based on sleep history, habitual bedtime is between 10:00 PM and 1:00 AM
Mean latency to persistent sleep of greater than 20 minutes on two consecutive screening nights with neither night less than 15 minutes
A mean of 60 minutes of wake time during the 480 minutes in bed across two nights with no night less than 45 minutes
Based on sleep history, normally uses pharmacological assistance to sleep 0 to 4 times per week in the last 3 months
Exclusion Criteria
Known hypersensitivity to ramelteon or related compounds, including melatonin, and melatonin related compounds
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
Sleep schedule changes required by employment (eg, shift worker) within three months prior to the administration of single-blind study medication
Flown across greater than three time zones within 7 days prior to or during screening
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
Has ever had a history of seizures, sleep apnea, restless leg syndrome, periodic leg movement syndrome, chronic obstructive pulmonary disease or fibromyalgia
History of psychiatric disorder within the past 6 months
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
History of drug abuse within the past 12 months, as defined in Diagnostic & Statistical Manual of Mental Disorders, 4th Edition Revised
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
Apnea hypopnea index (per hour of sleep) greater than 10 as seen on the first polysomnogram screening night
Periodic Leg Movement Syndrome with arousal index (per hour of sleep) greater than 10 as seen on the first polysomnogram screening night
Positive urine drug screen at Screening Visit 1 or any of the polysomnogram assessment visits
Positive breathalyzer test on any of the polysomnogram assessment visits
Uses tobacco products (including nicotine gum and patch) or any other products that may interfere with the sleep wake cycle during nightly awakenings
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.
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
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:
Anxiolytics
Sedatives
Hypnotics
CNS active drugs (including herbal)
Antidepressants
Narcotic analgesics
Anticonvulsants
Beta blockers
Sedating H1 antihistamines
St. John's Wort
Systemic steroids
Kava-kava
Respiratory stimulants
Ginkgo-biloba
Decongestants
Over-the-counter and prescription stimulants
Antipsychotics
Over-the-counter and prescription diet aids
Muscle Relaxants
Melatonin and all other drugs or supplements known to affect sleep/wake function
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
History of hepatitis B or hepatitis C