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Stilnox Treatment in Elderly Patients With Insomnia (STEP)

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: NCT00359229
Recruitment Status : Completed
First Posted : August 1, 2006
Last Update Posted : September 15, 2009
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE July 31, 2006
First Posted Date  ICMJE August 1, 2006
Last Update Posted Date September 15, 2009
Study Start Date  ICMJE July 2006
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2008)
Pittsburgh Sleep Quality Index (PSQI) score [ Time Frame: At 1 week versus baseline ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 31, 2006)
Pittsburgh Sleep Quality Index (PSQI) score at 1 week vs baseline
Change History Complete list of historical versions of study NCT00359229 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2008)
  • Pittsburgh Sleep Quality Index score [ Time Frame: At 3 weeks versus baseline ]
  • Subject sleeping efficacy variable [ Time Frame: At 1 week and 3 weeks versus baseline ]
  • Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale (HAMA) score [ Time Frame: At 3 weeks versus baseline ]
  • Adverse events (AE) and Serious adverse events (SAE) reports [ Time Frame: Throughout the study period ]
  • General Lab tests including hepatic and renal function [ Time Frame: At 3 weeks versus baseline ]
  • Vital signs [ Time Frame: At 1 week and 3 weeks versus baseline ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2006)
  • Pittsburgh Sleep Quality Index score at 3 weeks vs baseline
  • Subject sleeping efficacy variable at 1 week and 3 weeks vs baseline
  • Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale (HAMA) score at 3 weeks vs baseline
  • Adverse events (AE) and Serious adverse events (SAE) reports
  • Lab tests at 3 weeks vs baseline
  • Vital signs at 1 week and 3 weeks vs baseline
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stilnox Treatment in Elderly Patients With Insomnia
Official Title  ICMJE A Multicentre Prospective, Open Label ,3 Weeks Phase IV Study to Evaluate the Efficacy and Safety in Elder Patients With Insomnia in China
Brief Summary

Primary objective:

1. To evaluate the efficacy of Zolpidem 5mg for 1 week in elderly patients with insomnia in China

Secondary objectives:

  1. To evaluate the safety of Zolpidem 5mg for 3 weeks in elderly patients with insomnia in China.
  2. To evaluate the efficacy of Zolpidem 5mg for 3 weeks in elderly patients with insomnia in China
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Insomnia
Intervention  ICMJE Drug: Zolpidem
Administration of Zolpidem 5mg
Study Arms  ICMJE Experimental: 1
For 3 weeks
Intervention: Drug: Zolpidem
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: September 4, 2008)
115
Original Enrollment  ICMJE
 (submitted: July 31, 2006)
180
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Primary out-patient insomniac patient defined by DSM-IV criteria
  • Insomnia history lasted at least 3 months , this history must include a self-reported usual sleep latency of 30 minutes or more and either 3 or more awakenings per night on average or a usual total sleep time of ≤6.5 hours

Exclusion Criteria:

  • Usage of hypnotics within the previous 1-3 weeks before inclusion depending on the half-life of the hypnotics that would affect the study effect
  • Concomitant usage of other hypnotics (benzodiazepines and Non-benzodiazepines) during the course if the study.
  • Concomitant usage of the following Central Nervous System active medicine : antipsychotics , antidepressants ,anxiolytics, lithium and other psychotropic drugs.
  • The score of Hamilton Depression Rating Scale (HAMD-24 ) more than 17.
  • The score of Hamilton Anxiety Rating Scale (HAMA-14 ) more than 14.
  • Patients having known hypersensitivity to Stilnox or any of the ingredients in the products
  • Patient with severe respiratory insufficiency
  • Patients suffering from sleep apnoea syndrome
  • Patients with known severe hepatic (risk of encephalopathy) and /or renal insufficiency, or other severe organ diseases
  • Patients suffering from severe myasthenia gravis
  • Patients with the previous history of drug abuse, drug dependence and drug addiction
  • Any other disease state or major psychiatric condition that might affect study result

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 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries China
 
Administrative Information
NCT Number  ICMJE NCT00359229
Other Study ID Numbers  ICMJE ZOLPI_L_01540
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: Bruno Jolain Sanofi
PRS Account Sanofi
Verification Date September 2009

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