NCT00425243

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,025

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Aug 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 19, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 22, 2007

Completed
Last Updated

April 6, 2009

Status Verified

April 1, 2009

Enrollment Period

1.4 years

First QC Date

January 19, 2007

Last Update Submit

April 3, 2009

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

primary insomniachronic insomnia

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • 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.

Interventions

zolpidem-MR (SL800750)DRUG

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Malvern, Pennsylvania, 19355, United States

Location

Related Publications (1)

  • 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.

    PMID: 18220081RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • ICD CSD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 19, 2007

First Posted

January 22, 2007

Study Start

August 1, 2004

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

April 6, 2009

Record last verified: 2009-04

Locations

US(1)