Status:
TERMINATED
Comparison of Volinanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties
Lead Sponsor:
Sanofi
Conditions:
Sleep Initiation and Maintenance Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- Out-patients with Primary Insomnia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria
Exclusion
- Based on patient's information, the patient has spent less than 6.5 hours or more than 9.0 hours, in bed, each night, over the preceding two weeks
- Based on patient's information, the patient complains of less than one hour of wakefulness after sleep onset for at least 3 nights per week over the preceding month
- Disturbances of sleep maintenance parameters based on the patient's sleep questionnaire during the run-in period differing from pre-defined criteria.
- Pregnant or breastfeeding women and women of childbearing potential without effective contraceptive method of birth control
- Night shift workers and individuals who nap 3 or more times per week
- Consumption of xanthine-containing beverages (i.e., tea, coffee or cola) that comprises more than 5 cups or glasses per day
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00788515
Start Date
November 1 2008
End Date
January 1 2009
Last Update
August 28 2009
Active Locations (3)
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1
Sanofi-Aventis Administrative Office
Paris, France
2
Sanofi-Aventis Administrative Office
Barcelona, Spain
3
Sanofi-Aventis Administrative Office
Bromma, Sweden