Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00630175
Other study ID # EFC5202
Secondary ID
Status Completed
Phase Phase 3
First received February 26, 2008
Last updated May 15, 2009
Start date September 2003
Est. completion date February 2004

Study information

Verified date May 2009
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Health CanadaAustralia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 113
Est. completion date February 2004
Est. primary completion date February 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Sleep Initiation and Maintenance Disorders

Intervention

Drug:
zolpidem-MR (modified release)

zolpidem (SL800750)

placebo


Locations

Country Name City State
Australia Sanofi-Aventis Administrative Office Macquarie Park
Canada Sanofi-Aventis Administrative Office Laval
United States Sanofi-Aventis Administrative Office Bridgewater New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Polysommography (PSG) wake time after sleep onset (WASO)
Secondary PSG parameters, Patient's sleep questionnaire, Patient's global impression, Relative degree of satisfaction with the different study drugs
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Recruiting NCT05000528 - Evaluation of the Effectiveness of Patient Therapeutic Education on Chronic Insomnia N/A
Completed NCT04661306 - The Better Sleep for Supporters With Insomnia Study N/A
Completed NCT03673397 - The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression N/A
Completed NCT01784614 - A Study of LY2624803 in Japanese Participants With Transient Insomnia Phase 1
Completed NCT00365261 - Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer Phase 4
Completed NCT00380003 - Efficacy Study of EVT 201 to Treat Insomnia Phase 2
Completed NCT00183378 - Using Behavioral Programs to Treat Sleep Problems in Individuals With Alzheimer's Disease N/A
Completed NCT00946530 - Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease N/A
Completed NCT00097604 - Effects of Valerian on Sleep in Healthy Older Adults Phase 2
Completed NCT00079664 - Comparing Tai Chi Training to a Low-Stress Physical Activity to Enhance Sleep in Older Adults Phase 1
Completed NCT00044629 - Combined Behavioral/Pharmacological Therapy for Insomnia Phase 2
Completed NCT01154023 - Behavioral Intervention for Insomnia in Older Adults N/A
Recruiting NCT04417153 - Who Benefits More? Optimising Mindfulness Based Interventions for Improved Psychological Outcomes
Completed NCT04560595 - Remote Guided Caffeine Reduction N/A
Recruiting NCT04986007 - Addressing Nocturnal Sleep/Wake Effects on Risk of Suicide in Older Adults N/A
Completed NCT03852966 - Better Sleep in Psychiatric Care - ADHD Pilot Study N/A
Terminated NCT00750919 - Twenty-six Week Extension Trial of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia (176003/P05721/MK-8265-007) Phase 3
Recruiting NCT04550507 - Mind-Body Interventions to Mitigate Effects of Media Use on Sleep in Early Adolescents N/A
Recruiting NCT05226585 - Mechanisms of Change in Cognitive Behavioral Therapy for Insomnia (CBTi) N/A