NCT00630175

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
113

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2003

Shorter than P25 for phase_3

Geographic Reach
3 countries

3 active sites

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

September 1, 2003

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 6, 2008

Completed
Last Updated

May 18, 2009

Status Verified

May 1, 2009

Enrollment Period

5 months

First QC Date

February 26, 2008

Last Update Submit

May 15, 2009

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

Insomnia

Outcome Measures

Primary Outcomes (1)

  • Polysommography (PSG) wake time after sleep onset (WASO)

Secondary Outcomes (1)

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

Interventions

zolpidem-MR (modified release)DRUG
zolpidem (SL800750)DRUG
placeboDRUG

Eligibility Criteria

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, 08807, United States

Location

Sanofi-Aventis Administrative Office

Macquarie Park, Australia

Location

Sanofi-Aventis Administrative Office

Laval, Canada

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

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
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 26, 2008

First Posted

March 6, 2008

Study Start

September 1, 2003

Primary Completion

February 1, 2004

Study Completion

February 1, 2004

Last Updated

May 18, 2009

Record last verified: 2009-05

Locations

US(1)AU(1)CA(1)