Efficacy and Safety of Zolpidem-MR Administered Over a Long Term Period as Needed for Insomnia (ZOLONG)

Phase 3

Completed

• Conditions: Sleep Initiation and Maintenance Disorders

• Registration Number: NCT00425243
• Lead Sponsor: Sanofi

Brief Summary

The primary objective of the study is to evaluate the hypnotic efficacy of zolpidem-MR 12.5 mg in comparison with placebo, when administered over a long-term period, on an "as needed" basis, in patients with chronic primary insomnia.

Secondary objectives of the study are to evaluate the drug taking behavior over a long-term period and the clinical safety and tolerability of zolpidem-MR 12.5 mg in comparison to placebo administered over a long-term period, on an as needed basis.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Primary Completion: 2006-01
• Study Completion: 2006-01
• Study First Submitted: 2007-01-19
• Study First Submitted QC: 2007-01-19
• Study First Posted: 2007-01-22
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-03
• Last Update Posted: 2009-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1025

Inclusion Criteria

• patients with chronic primary insomnia

The investigator will evaluate whether there are other reasons why a patient may not participate.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary efficacy variable is item 1 (which assessed sleep aid) of the Patient Global Impression (PGI) scale at week 12.

Secondary Outcome Measures

Name	Time	Method
Main secondary variables are the Clinical Global Impression (CGI) improvement item and to items 2, 3, and 4 of the PGI scale at week 12.

Trial Locations

Locations (1)

Sanofi-Aventis; 🇺🇸 Malvern, Pennsylvania, United States