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Efficacy of Ramelteon in Adults With Chronic Insomnia
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Subjective Response to Treatment With Ramelteon in Adult Subjects With Chronic Insomnia by Utilizing an Interactive Voice Response System (IVRS) for Collecting Diary Data
2 other identifiers
interventional
1,081
1 country
43
Brief Summary
The purpose of this study is to evaluate subjectively reported treatment effects of ramelteon, once daily (QD), in adults with chronic insomnia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2005
Shorter than P25 for phase_3
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 2, 2008
CompletedFirst Posted
Study publicly available on registry
May 6, 2008
CompletedFebruary 28, 2012
February 1, 2012
6 months
May 2, 2008
February 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Subjective Sleep Latency determined through subject responses on morning questionnaire.
Day 8
Secondary Outcomes (10)
Mean Subjective Sleep Latency.
Day 15
Mean Subjective Total Sleep
Day 8
Mean Subjective Total Sleep
Day 15
Adverse Events.
Days 1, 8, and 15 or Final Visit.
Clinical Laboratory Tests Hematology
Day 15 or Final Visit.
- +5 more secondary outcomes
Study Arms (2)
Ramelteon 8 mg QD
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
- Has had primary chronic insomnia as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised for at least 3 months.
- Reports a history of subjective sleep latency greater than or equal to 60 min and a subjective total sleep time less than 6.5 hours.
- Habitual bedtime is between 10:00 PM and 1:00 AM.
- Willing to have a fixed bedtime and agrees to go to bed within plus or minus 30 minutes of the habitual bedtime during the entire study.
- Consistent access to a touch tone phone and are willing to complete telephone questionnaires twice daily during participation in the study.
- Willing to remain in bed for at least 6.5 hours each night during the entire study.
- Used pharmacological assistance to sleep 0-4 times per week in the last 3 months.
- Must complete the morning questionnaire on at least 4 of the first 7 mornings after Screening Visit 1.
- On at least 3 of the first 5 nights of single-blind placebo treatment, the subject must have a subjective sleep latency of greater than or equal to 45 minutes.
- On at least 3 of the first 5 nights of single-blind placebo treatment, the subject must have a subjective total sleep time of less than 6.5 hours.
You may not qualify if:
- Known hypersensitivity to ramelteon or related compounds, including melatonin, and 5-hydroxytryptophan.
- Participated in any other investigational study and/or took any investigational drug within 30 days prior to the first dose of single-blind study medication.
- Sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the first night of single-blind study medication.
- Has flown across greater than 3 time zones within 7 days prior to screening, or will travel across 2 or more time zones during the course of the study.
- Participated in a weight loss program or has substantially altered exercise routine within 30 days prior to the first night of singleblind study medication.
- Ever had a history of seizures, sleep apnea, and/or chronic obstructive pulmonary disease.
- History of psychiatric disorder within the past 6 months.
- History of fibromyalgia.
- 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 more than 2 alcoholic drinks per day.
- Current significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, 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.
- Uses tobacco products or any other products that may interfere with the sleep wake cycle 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(s) that in the Investigator's opinion would:
- +22 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (43)
Unknown Facility
Mesa, Arizona, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Scottsdale, Arizona, United States
Unknown Facility
Hot Springs, Arkansas, United States
Unknown Facility
Cerritos, California, United States
Unknown Facility
La Jolla, California, United States
Unknown Facility
La Mesa, California, United States
Unknown Facility
Oakland, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Bay Harbor Island, Florida, United States
Unknown Facility
Brandon, Florida, United States
Unknown Facility
Clearwater, Florida, United States
Unknown Facility
DeLand, Florida, United States
Unknown Facility
Fort Lauderdale, Florida, United States
Unknown Facility
Fort Myers, Florida, United States
Unknown Facility
Hollywood, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Pembroke Pines, Florida, United States
Unknown Facility
Pinellas Park, Florida, United States
Unknown Facility
Vero Beach, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Austell, Georgia, United States
Unknown Facility
Macon, Georgia, United States
Unknown Facility
Boise, Idaho, United States
Unknown Facility
Northbrook, Illinois, United States
Unknown Facility
Prairie Village, Kansas, United States
Unknown Facility
Wichita, Kansas, United States
Unknown Facility
Louisville, Kentucky, United States
Unknown Facility
Frederick, Maryland, United States
Unknown Facility
Moorestown, New Jersey, United States
Unknown Facility
Menlius, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Williamsville, New York, United States
Unknown Facility
Salem, North Carolina, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Mogadore, Ohio, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Bristol, Tennessee, United States
Unknown Facility
Chattanooga, Tennessee, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Fairfax, Virginia, United States
Unknown Facility
Tacoma, Washington, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
VP Clinical Science
Takeda
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2008
First Posted
May 6, 2008
Study Start
February 1, 2005
Primary Completion
August 1, 2005
Study Completion
August 1, 2005
Last Updated
February 28, 2012
Record last verified: 2012-02