Comparison of Volinanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties
NCT ID: NCT00788515
Last Updated: 2009-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
33 participants
INTERVENTIONAL
2008-11-30
2009-01-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Volinanserin (M100907)
2 mg tablets QD
2
Lormetazepam
1 mg tablets (overencapsulated) QD
Interventions
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Volinanserin (M100907)
2 mg tablets QD
Lormetazepam
1 mg tablets (overencapsulated) QD
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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ICD CSD
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Paris, , France
Sanofi-Aventis Administrative Office
Barcelona, , Spain
Sanofi-Aventis Administrative Office
Bromma, , Sweden
Countries
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Other Identifiers
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EudraCT: 2008-001492-30
Identifier Type: -
Identifier Source: secondary_id
EFC10550
Identifier Type: -
Identifier Source: org_study_id