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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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ClinicalTrials.gov Identifier: NCT00630175
Recruitment Status : Completed
First Posted : March 6, 2008
Last Update Posted : May 18, 2009
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE February 26, 2008
First Posted Date  ICMJE March 6, 2008
Last Update Posted Date May 18, 2009
Study Start Date  ICMJE September 2003
Actual Primary Completion Date February 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2008)
Polysommography (PSG) wake time after sleep onset (WASO)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00630175 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2008)
PSG parameters, Patient's sleep questionnaire, Patient's global impression, Relative degree of satisfaction with the different study drugs
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Sleep Initiation and Maintenance Disorders
Intervention  ICMJE
  • Drug: zolpidem-MR (modified release)
  • Drug: zolpidem (SL800750)
  • Drug: placebo
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 5, 2008)
113
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2004
Actual Primary Completion Date February 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00630175
Other Study ID Numbers  ICMJE EFC5202
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ICD Study Director, sanofi-aventis
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ICD CSD Sanofi
PRS Account Sanofi
Verification Date May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP