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

May 15, 2009 updated by: Sanofi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Macquarie Park, Australia
        • Sanofi-Aventis Administrative Office
  • Canada
      • Laval, Canada
        • Sanofi-Aventis Administrative Office
  • United States
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Polysommography (PSG) wake time after sleep onset (WASO)

Secondary Outcome Measures

Outcome Measure
PSG parameters, Patient's sleep questionnaire, Patient's global impression, Relative degree of satisfaction with the different study drugs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (ACTUAL)

February 1, 2004

Study Completion (ACTUAL)

February 1, 2004

Study Registration Dates

First Submitted

February 26, 2008

First Submitted That Met QC Criteria

March 5, 2008

First Posted (ESTIMATE)

March 6, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 18, 2009

Last Update Submitted That Met QC Criteria

May 15, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC5202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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