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Efficacy and Safety Assessment of ZOlpidem (Stilnox CR) in Patients With Chronic insomNIA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01024192
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : October 5, 2010
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE November 30, 2009
First Posted Date  ICMJE December 2, 2009
Last Update Posted Date October 5, 2010
Study Start Date  ICMJE November 2009
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2009)
Improvement of the Clinical Global Impression (CGI) score [ Time Frame: At day 84 (visit 5) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01024192 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2009)
  • Illness severity and average change during the study [ Time Frame: At day 1 (baseline), day 14 (visit 2), day 28 (visit 3), day 56 (visit 4) and day 84 (visit 5) ]
  • Pittsburgh Sleep Quality Index (PSQI) score [ Time Frame: At day 1 (baseline), day 28 (visit 3), day 56 (visit 4) and day 84 (visit 5) ]
  • Patient satisfaction questionnaire [ Time Frame: At day 84 (visit 5) ]
  • Safety evaluation via Adverse events reported [ Time Frame: At day 14 (visit 2), day 28 (visit 3), day 56 (visit 4) and day 84 (visit 5) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Assessment of ZOlpidem (Stilnox CR) in Patients With Chronic insomNIA
Official Title  ICMJE Efficacy and Safety Assessment of ZOlpidem (Stilnox CR) Administered on as Needed Basis in Patients With Chronic insomNIA
Brief Summary

Primary Objective:

To evaluate the efficacy and safety of the use of Stilnox CR in Mexican patients with chronic insomnia at the prescription conditions of daily practice

Secondary Objective:

To evaluate the satisfaction of the patient with chronic insomnia with Stilnox CR over an as needed basis.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sleep Disorders
Intervention  ICMJE Drug: ZOLPIDEM SL800750

Pharmaceutical form: Zopidem 12.5 mg tablets

Route of administration: Oral

Dose regimen:One tablet at bed time and as needed (the patients choose which night they take the tablet without limit of number of nights)

Study Arms  ICMJE Experimental: 1
Zolpidem 12.5mg tablet at bed time during 12 weeks
Intervention: Drug: ZOLPIDEM SL800750
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 4, 2010)
135
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2009)
130
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

- Primary insomnia diagnosis (difficulty for initiating sleep, or maintaining sleep to wake up to early in the morning, or to present a restless sleep) which causes clinically significant disturbances in the areas of social, work functioning or other important areas

Exclusion criteria:

  • Serious, severe and/or acute respiratory impairment
  • Severe liver impairment
  • Hypersensitivity to the formulation components or to some of its active metabolites
  • Pregnant or breast-feeding women Patients with important associated disorders in SNC and specially psychotic disorders
  • Patients with the probability of using alcoholic beverages concomitantly (as a precaution measure)
  • Chronic use of benzodiazepines

Moreover, in order to follow the international regulations in terms of the use and handling of hypnotic compounds, and to guarantee the appropriate study performance, no patients with one or more of the following characteristics should be included:

  • Patients who cannot comply to follow-up
  • Patients who have any drug abuse problem
  • Individuals who work changing night shifts or with pathological snoring
  • Presence (or suspicion) of sleep apnea, periodical legs movements or restless legs syndrome

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01024192
Other Study ID Numbers  ICMJE ZOLPI_L_04134
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical Affairs Study Director, sanofi-aventis
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Affairs Sanofi
PRS Account Sanofi
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP