Back to resultsEvaluation of the Hypnotic Properties of Zolpidem-MR 12.5 mg and Zolpidem 10 mg Marketed Product Compared to Placebo in Patients With Primary Insomnia
Primary Purpose
Sleep Initiation and Maintenance Disorders
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
zolpidem-MR (modified release)
zolpidem (SL800750)
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders focused on measuring Insomnia
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
Sites / Locations
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
Outcomes
Primary Outcome Measures
Polysommography (PSG) wake time after sleep onset (WASO)
Secondary Outcome Measures
PSG parameters, Patient's sleep questionnaire, Patient's global impression, Relative degree of satisfaction with the different study drugs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00630175
Brief Title
Evaluation of the Hypnotic Properties of Zolpidem-MR 12.5 mg and Zolpidem 10 mg Marketed Product Compared to Placebo in Patients With Primary Insomnia
Official Title
Evaluation of the Hypnotic Properties of Zolpidem-MR 12.5 mg and Zolpidem 10 mg Marketed Product Compared to Placebo in Patients With Primary Insomnia. A Double-Blind, Randomized, Placebo-Controlled,Three Way Cross-Over Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
February 2004 (Actual)
Study Completion Date
February 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief Summary
The primary objective is to evaluate the hypnotic efficacy of zolpidem-MR (modified release) 12.5 mg and zolpidem 10 mg marketed product in comparison with placebo in patients with primary insomnia and sleep maintenance difficulties, using polysomnography (PSG) recordings and patient sleep questionnaires.
The secondary objective is to evaluate the clinical safety and tolerability of zolpidem-MR 12.5 mg and zolpidem 10 mg marketed product in comparison with placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders
Keywords
Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
zolpidem-MR (modified release)
Intervention Type
Drug
Intervention Name(s)
zolpidem (SL800750)
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Polysommography (PSG) wake time after sleep onset (WASO)
Secondary Outcome Measure Information:
Title
PSG parameters, Patient's sleep questionnaire, Patient's global impression, Relative degree of satisfaction with the different study drugs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Sanofi-Aventis Administrative Office
City
Macquarie Park
Country
Australia
Facility Name
Sanofi-Aventis Administrative Office
City
Laval
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Hypnotic Properties of Zolpidem-MR 12.5 mg and Zolpidem 10 mg Marketed Product Compared to Placebo in Patients With Primary Insomnia
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