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
848 participants
INTERVENTIONAL
2002-12-31
2003-09-30
Brief Summary
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Detailed Description
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Ramelteon is a 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 is designed to determine the safety and efficacy of 35-day treatment of chronic insomnia with Ramelteon, using subjective measures of sleep. Total subject participation time in this study is expected to be approximately 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 daily for up to 5 weeks.
Ramelteon 16 mg QD
Ramelteon
Ramelteon, 16 mg, tablets, orally, once daily for up to 5 weeks.
Placebo
Placebo
Ramelteon placebo-matching tablets, orally, once daily for up to 5 weeks.
Interventions
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Ramelteon
Ramelteon, 8 mg, tablets, orally, once daily for up to 5 weeks.
Ramelteon
Ramelteon, 16 mg, tablets, orally, once daily for up to 5 weeks.
Placebo
Ramelteon placebo-matching tablets, orally, once daily for up to 5 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has had primary insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders, Text Revision and a history of daytime complaint(s) associated with disturbed sleep.
* Subjective sleep latency greater than or equal to 45 minutes and a subjective total sleep time less than or equal to 6.5 hours per night for at least 3 nights during the week of the lead-in period, based on subject diary.
* Habitual bedtime is between 8:30 PM and 12:00 AM.
* 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 day of single-blind study medication, whichever is longer.
* Sleep schedule changes required by employment (eg, shift worker) within three months prior to the first day 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 day of single-blind study medication.
* Has ever had a history of seizures, sleep apnea, chronic obstructive pulmonary disease, restless leg syndrome, 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.
* 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 day of single-blind study medication.
* Uses tobacco products during nightly awakenings.
* 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.
* Any additional condition 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 that may interfere with evaluation of the study medication, including:
* melatonin or other drugs or supplements known to affect sleep/wake function.
* anxiolytics
* hypnotics
* antidepressants
* anticonvulsants
* sedating H1 antihistamines
* systemic steroids
* respiratory stimulants and 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
* beta blockers
* melatonin
* St. John's Wort
* kava-kava
* 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
Mobile, Alabama, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Tempe, Arizona, United States
Hot Springs, Arkansas, United States
Little Rock, Arkansas, United States
Anaheim, California, United States
Chula Vista, California, United States
Irvine, California, United States
La Mesa, California, United States
Newport Beach, California, United States
Northridge, California, United States
Oakland, California, United States
Redlands, California, United States
Spring Valley, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Clearwater, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Longwood, Florida, United States
Pembroke Pines, Florida, United States
Safety Harbor, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Vero Beach, Florida, United States
West Palm Beach, Florida, United States
Winter Park, Florida, United States
Atlanta, Georgia, United States
Blairsville, Georgia, United States
Decatur, Georgia, United States
Macon, Georgia, United States
Marietta, Georgia, United States
Arlington Heights, Illinois, United States
Chicago, Illinois, United States
Danville, Indiana, United States
Evansville, Indiana, United States
Shawnee Mission, Kansas, United States
Bethesda, Maryland, United States
Brockton, Massachusetts, United States
Detroit, Michigan, United States
Hattiesburg, Mississippi, United States
St Louis, Missouri, United States
Lawrenceville, New Jersey, United States
Moorestown, New Jersey, United States
Albuquerque, New Mexico, United States
Mineola, New York, United States
Williamsville, New York, United States
Cary, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Beachwood, Ohio, United States
Cincinnati, Ohio, United States
Oklahoma City, Oklahoma, United States
Altoona, Pennsylvania, United States
Jenkintown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Sellersville, Pennsylvania, United States
Warwick, Rhode Island, United States
Mt. Pleasant, South Carolina, United States
Johnson City, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Virginia Beach, Virginia, United States
Gig Harbor, Washington, United States
Countries
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Related Links
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Other Identifiers
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U1111-1114-3130
Identifier Type: REGISTRY
Identifier Source: secondary_id
01-02-TL-375-020
Identifier Type: -
Identifier Source: org_study_id