Subjective Efficacy of Ramelteon on Sleep in Adults With Chronic Insomnia.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Demonstrate the Subjective Treatment Effects of Ramelteon on Sleep Using a Post Sleep Questionnaire - Interactive Voice Response System (PSQ-IVRS) in an "At-Home Setting" in an Adult Population With Chronic Insomnia|
- Average subjective Sleep Latency from Day 15 to Day 21 [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
- Subjective Measures of Sleep Latency. [ Time Frame: Weeks 1 and 2 or Final Visit ] [ Designated as safety issue: No ]
- Subjective Total Sleep Time. [ Time Frame: Weeks 1, 2 and 3 or Final Visit ] [ Designated as safety issue: No ]
- Wake Time after Sleep Onset [ Time Frame: Weeks 1, 2 and 3 or Final Visit ] [ Designated as safety issue: No ]
- Number of Awakenings. [ Time Frame: Weeks 1, 2 and 3 or Final Visit ] [ Designated as safety issue: No ]
- Quality of Sleep. [ Time Frame: Weeks 1, 2 and 3 or Final Visit ] [ Designated as safety issue: No ]
- Rebound insomnia assessed from Nights 22 to 28 via self-reported sleep latency. [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
|Study Start Date:||October 2006|
|Study Completion Date:||September 2007|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
|Experimental: Ramelteon 8 mg QD||
Ramelteon 8mg, tablets, orally, once nightly for up to 28 days.
|Placebo Comparator: Placebo QD||
Ramelteon placebo-matching tablets, orally, once nightly for up to 28 days.
Approximately 60 to 70 million adults in the United States alone are affected by insomnia. Daytime symptoms of insomnia include tiredness, lack of energy, difficulty concentrating, and irritability. Recent epidemiologic research focusing on the quality of life has identified significant insomnia-related conditions that relate to work productivity, health care utilization, and risk of depression. Insomnia is associated with diminished work output, absenteeism, and greater rates of accidents.
Ramelteon is marketed for the treatment of insomnia characterized by difficulty with sleep onset under the brand name of Rozerem™.
This study will be comprised of two groups of subjects, 1) an outpatient group and 2) an inpatient group. The inpatient group will be used as reference arm as previously conducted studies in the sleep laboratory setting. Study participation is anticipated to be about 50 days (approximately 1.75 months).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00414102
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|Study Director:||Medical Director Clinical Science||Takeda Global Research & Development Center|