Subjective Efficacy of Ramelteon on Sleep in Adults With Chronic Insomnia.
Recruiting in Palo Alto (17 mi)
+51 other locations
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Waitlist Available
Sponsor: Takeda
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
The purpose of this study is to determine the subjective treatment effects of ramelteon, once daily (QD), on sleep using a post sleep questionnaire-interactive voice response system in adults with chronic insomnia.
Eligibility Criteria
Inclusion Criteria
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.
Body mass index between 18 and 34, inclusive.
Based on sleep history, has had chronic insomnia for at least 3 months.
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Treatment Details
Interventions
- Placebo (Other)
- Ramelteon (Melatonin Receptor Agonist)
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ramelteon 8 mg QDExperimental Treatment1 Intervention
Group II: Placebo QDPlacebo Group1 Intervention
Ramelteon is already approved in United States, Japan for the following indications:
🇺🇸 Approved in United States as Rozerem for:
- Insomnia characterized by difficulty with sleep onset
🇯🇵 Approved in Japan as Rozerem for:
- Insomnia
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NCT00414102Akron, OH
NCT00414102Staten Island, NY
NCT00414102Colorado Springs, CO
NCT00414102Boise, ID
More Trial Locations
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Who Is Running the Clinical Trial?
TakedaLead Sponsor