Study of Efficacy of Ramelteon in Adults With Chronic Insomnia
NCT ID: NCT00671125
Last Updated: 2012-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
405 participants
INTERVENTIONAL
2003-01-31
2003-09-30
Brief Summary
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Detailed Description
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Ramelteon is a selective melatonin-1 receptor agonist under global development by Takeda Chemical Industries, Ltd., for the treatment of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders.
This study will determine the safety and efficacy of 35-day treatment of chronic insomnia with Ramelteon using polysomnography and subjective measures of sleep. Participation in this study is anticipated to be about 2 months.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ramelteon 8 mg QD
Ramelteon
Ramelteon 8 mg, tablets, orally, once nightly for up to 5 weeks.
Ramelteon 16 mg QD
Ramelteon
Ramelteon 16 mg, tablets, orally, once nightly for up to 5 weeks.
Placebo
Placebo
Ramelteon placebo-matching tablets, orally, once nightly for up to 5 weeks.
Interventions
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Ramelteon
Ramelteon 8 mg, tablets, orally, once nightly for up to 5 weeks.
Ramelteon
Ramelteon 16 mg, tablets, orally, once nightly for up to 5 weeks.
Placebo
Ramelteon placebo-matching tablets, orally, once nightly for up to 5 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Females who are not of childbearing potential must be postmenopausal for 1 year or have history of hysterectomy and/or oophorectomy.
* Primary insomnia as defined by the DSM-IV-TRTM for at least 3 months and as defined by subjective sleep latency (sSL) greater than or equal to 30 minutes, subjective total sleep time (sTST) less than or equal to 6.5 hours per night, and daytime complaint(s) associated with disturbed sleep.
* Mean latency of greater than or equal to 20 minutes on 2 consecutive screening nights with neither night less than 15 minutes. Also, a mean of 60 minutes of wake time during the 480 minutes in bed across two nights with no night less than 45 minutes screening nights with neither night less than 15 minutes. Also, a mean of 60 minutes of wake time during the 480 minutes in bed across two nights with no night less than 45 minutes.
* Habitual bedtime is between 8:30 p.m. and 12:00 a.m.
* Body mass index between 18 and 34, inclusive.
Exclusion Criteria
* Previously participated in a study involving Ramelteon.
* Participated in any other investigational study and/or taken any investigational drug within 30 days or five half-lives prior to the first night single-blind study medication, whichever is longer.
* Sleep schedule changes required by employment (e.g. shift worker) within three months prior to the first night of single-blind study medication, or has flown across greater than three time zones within seven days prior to screening.
* Participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the first night of single blind study medication.
* Ever had a history of seizures, sleep apnea, chronic obstructive pulmonary disease, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder.
* History of psychiatric disorder (including anxiety or depression) within the past 12 months.
* History of drug addiction or drug abuse within the past 12 months.
* History of alcohol abuse within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised and/or regularly consumes 4 or more alcoholic drinks per day.
* Current significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic disease, unless currently controlled and stable with protocol-allowed medication 30 days prior to the first night of single-blind study medication.
* Uses tobacco products during nightly awakenings.
* Used melatonin, 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 first day of single-blind study medication.
* Used any central nervous system medication within 1 week (or 5 half lives of the drug, whichever is longer) prior to the first day of single-blind study medication. These medications must not have been used to treat psychiatric disorders.
* Any clinically important abnormal finding as determined by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator.
* Positive hepatitis panel.
* Positive urine drug screen including alcohol at screening or a positive breathalyzer test at each check-in.
* Apnea hypopnea index (per hour of sleep) greater than 10 as seen on polysomnogram, on the first night of the polysomnogram screening.
* Periodic leg movement with arousal index (per hour of sleep) greater than 10 as seen on polysomnogram, on the first night of polysomnogram screening.
* Any additional condition(s) that in the Investigator's opinion would:
* affect sleep/wake function
* prohibit the subject from completing the study
* not be in the best interest of the subject.
* Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication, including:
* Anxiolytics
* Hypnotics
* Antidepressants
* Anticonvulsants
* Sedating H1 antihistamines
* Systemic steroids
* Respiratory stimulants (eg, theophylline)
* Decongestants
* Over-the-counter and prescription stimulants
* Over-the-counter and prescription diet aids
* Central nervous system active drugs (including herbal preparations with central nervous system effects)
* Narcotic analgesics
* All beta blockers
* Melatonin
* St. John's Wort
* Kavakava
* Gingko biloba
18 Years
64 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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VP Clinical Science
Role: STUDY_DIRECTOR
Takeda
Locations
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Birmingham, Alabama, United States
Scottsdale, Arizona, United States
Hot Springs, Arkansas, United States
Anaheim, California, United States
Oakland, California, United States
San Diego, California, United States
San Francisco, California, United States
Santa Monica, California, United States
Miami, Florida, United States
Pembroke Pines, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Overland Park, Kansas, United States
Crestview Hills, Kentucky, United States
Chevy Chase, Maryland, United States
Newton, Massachusetts, United States
Troy, Michigan, United States
Lincoln, Nebraska, United States
Las Vegas, Nevada, United States
New York, New York, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Lafayette Hill, Pennsylvania, United States
Austin, Texas, United States
Plano, Texas, United States
Countries
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References
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Zammit G, Erman M, Wang-Weigand S, Sainati S, Zhang J, Roth T. Evaluation of the efficacy and safety of ramelteon in subjects with chronic insomnia. J Clin Sleep Med. 2007 Aug 15;3(5):495-504.
Mini L, Wang-Weigand S, Zhang J. Ramelteon 8 mg/d versus placebo in patients with chronic insomnia: post hoc analysis of a 5-week trial using 50% or greater reduction in latency to persistent sleep as a measure of treatment effect. Clin Ther. 2008 Jul;30(7):1316-23. doi: 10.1016/s0149-2918(08)80056-2.
Osborne, T, Louis, M, Wang-Weigand, S and Jie, Z. Treatment of insomnia in women and the melatonin receptor agonist ramelteon (Rozerem). Women's Health Care: A Practical Journal for Nurse Practitioners. 2008; 7: (6): 24-30
Wang-Weigand S, McCue M, Ogrinc F, Mini L. Effects of ramelteon 8 mg on objective sleep latency in adults with chronic insomnia on nights 1 and 2: pooled analysis. Curr Med Res Opin. 2009 May;25(5):1209-13. doi: 10.1185/03007990902858527.
Related Links
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Other Identifiers
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U1111-1114-8329
Identifier Type: REGISTRY
Identifier Source: secondary_id
01-02-TL-375-021
Identifier Type: -
Identifier Source: org_study_id