Trials / Terminated
TerminatedNCT00788515
Comparison of Volinanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties
Comparison of the Safety and Efficacy of Volinanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties. A 4 Week,Randomized, Double-blind, Comparative, Parallel-group Study.
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 33 (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 volinanserin 2 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. 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 | Volinanserin (M100907) | 2 mg tablets QD |
| DRUG | Lormetazepam | 1 mg tablets (overencapsulated) QD |
Timeline
- Start date
- 2008-11-01
- Primary completion
- 2009-01-01
- Completion
- 2009-01-01
- First posted
- 2008-11-11
- Last updated
- 2009-08-28
Locations
3 sites across 3 countries: France, Spain, Sweden
Source: ClinicalTrials.gov record NCT00788515. Inclusion in this directory is not an endorsement.