Subjective Efficacy of Ramelteon on Sleep in Adults With Chronic Insomnia.
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|ClinicalTrials.gov Identifier: NCT00414102|
Recruitment Status : Completed
First Posted : December 21, 2006
Last Update Posted : June 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Insomnia||Drug: Ramelteon Drug: Placebo||Phase 4|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||552 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||October 2006|
|Primary Completion Date :||September 2007|
|Study Completion Date :||September 2007|
|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.
- Average subjective Sleep Latency from Day 15 to Day 21 [ Time Frame: Day 22 ]
- Subjective Measures of Sleep Latency. [ Time Frame: Weeks 1 and 2 or Final Visit ]
- Subjective Total Sleep Time. [ Time Frame: Weeks 1, 2 and 3 or Final Visit ]
- Wake Time after Sleep Onset [ Time Frame: Weeks 1, 2 and 3 or Final Visit ]
- Number of Awakenings. [ Time Frame: Weeks 1, 2 and 3 or Final Visit ]
- Quality of Sleep. [ Time Frame: Weeks 1, 2 and 3 or Final Visit ]
- Rebound insomnia assessed from Nights 22 to 28 via self-reported sleep latency. [ Time Frame: Day 29 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00414102
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|Study Director:||Medical Director Clinical Science||Takeda Global Research & Development Center|