Comparison of Eplivanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties
NCT ID: NCT00679900
Last Updated: 2010-11-30
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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COMPLETED
PHASE3
283 participants
INTERVENTIONAL
2008-04-30
2009-03-31
Brief Summary
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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.
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
QUADRUPLE
Study Groups
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1
eplivanserin (SR46349)
5 mg/day
2
lormetazepam
1 mg/day
Interventions
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eplivanserin (SR46349)
5 mg/day
lormetazepam
1 mg/day
Eligibility Criteria
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Inclusion Criteria
* At least 1 hour of wakefulness for at least 3 nights per week during the month preceding inclusion
* Disturbances of sleep maintenance criteria based on the patient's sleep questionnaire during the run-in period
Exclusion Criteria
* 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
* Insomnia secondary to a general medical condition
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
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Santiago, , Chile
Sanofi-Aventis Administrative Office
Tallinn, , Estonia
Sanofi-Aventis Administrative Office
Helsinki, , Finland
Sanofi-Aventis Administrative Office
Paris, , France
Sanofi-Aventis Administrative Office
Gouda, , Netherlands
Sanofi-Aventis Administrative Office
Lysaker, , Norway
Sanofi-Aventis Administrative Office
Porto Salvo, , Portugal
Sanofi-Aventis Administrative Office
Barcelona, , Spain
Countries
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Other Identifiers
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EudraCT 2007-003822-28
Identifier Type: -
Identifier Source: secondary_id
EFC10480
Identifier Type: -
Identifier Source: org_study_id