Trials / Completed
CompletedNCT00679900
Comparison of Eplivanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties
Comparison of the Safety and Efficacy of Eplivanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties. A 4 Week, Randomized, Double-blind,Comparative, Parallel-group Study
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 283 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective is to compare the potential for next-day residual effects of eplivanserin 5 mg/day and lormetazepam 1 mg/day by measuring the sleepiness in the morning using the patient's sleep questionnaire during 4 weeks of treatment in patients with chronic primary insomnia and sleep maintenance difficulties. The secondary objectives are to compare the clinical safety of both products, including the potential for rebound insomnia and withdrawal symptoms after treatment discontinuation, to compare the efficacy of both products on subjective sleep parameters and to compare the effects of both products on patient's daytime functioning.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | eplivanserin (SR46349) | 5 mg/day |
| DRUG | lormetazepam | 1 mg/day |
Timeline
- Start date
- 2008-04-01
- Primary completion
- 2009-03-01
- Completion
- 2009-03-01
- First posted
- 2008-05-19
- Last updated
- 2010-11-30
Locations
8 sites across 8 countries: Chile, Estonia, Finland, France, Netherlands, Norway, Portugal, Spain
Source: ClinicalTrials.gov record NCT00679900. Inclusion in this directory is not an endorsement.