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

Primary Purpose

Sleep Initiation and Maintenance Disorders

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

zolpidem-MR (SL800750)

About this trial

This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders focused on measuring primary insomnia, chronic insomnia

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

patients with chronic primary insomnia

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

Sites / Locations

Sanofi-Aventis

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00425243

First Posted

January 19, 2007

Last Updated

April 3, 2009

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00425243

Brief Title

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

Official Title

Evaluation of the Long-Term Efficacy and Safety of Zolpidem-MR 12.5 mg Compared to Placebo, When Both Are Administered Over a Long-Term Period "as Needed", in Patients With Chronic Primary Insomnia

Study Type

Interventional

2. Study Status

Record Verification Date

April 2009

Overall Recruitment Status

Completed

Study Start Date

August 2004 (undefined)

Primary Completion Date

January 2006 (Actual)

Study Completion Date

January 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

5. Study Description

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.

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

primary insomnia, chronic insomnia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1025 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

zolpidem-MR (SL800750)

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients with chronic primary insomnia The investigator will evaluate whether there are other reasons why a patient may not participate.

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

City

Malvern

State/Province

Pennsylvania

ZIP/Postal Code

19355

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

18220081

Citation

Krystal AD, Erman M, Zammit GK, Soubrane C, Roth T; ZOLONG Study Group. Long-term efficacy and safety of zolpidem extended-release 12.5 mg, administered 3 to 7 nights per week for 24 weeks, in patients with chronic primary insomnia: a 6-month, randomized, double-blind, placebo-controlled, parallel-group, multicenter study. Sleep. 2008 Jan;31(1):79-90. doi: 10.1093/sleep/31.1.79.

Results Reference

result

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

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