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Stilnox Treatment in Elderly Patients With Insomnia (STEP)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00359229
First received: July 31, 2006
Last updated: September 14, 2009
Last verified: September 2009
History of Changes
  Purpose

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

Condition Intervention Phase
Insomnia
 Drug: Zolpidem
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicentre Prospective, Open Label ,3 Weeks Phase IV Study to Evaluate the Efficacy and Safety in Elder Patients With Insomnia in China

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Pittsburgh Sleep Quality Index (PSQI) score [ Time Frame: At 1 week versus baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pittsburgh Sleep Quality Index score [ Time Frame: At 3 weeks versus baseline ] [ Designated as safety issue: No ]
  • Subject sleeping efficacy variable [ Time Frame: At 1 week and 3 weeks versus baseline ] [ Designated as safety issue: No ]
  • Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale (HAMA) score [ Time Frame: At 3 weeks versus baseline ] [ Designated as safety issue: No ]
  • Adverse events (AE) and Serious adverse events (SAE) reports [ Time Frame: Throughout the study period ] [ Designated as safety issue: Yes ]
  • General Lab tests including hepatic and renal function [ Time Frame: At 3 weeks versus baseline ] [ Designated as safety issue: No ]
  • Vital signs [ Time Frame: At 1 week and 3 weeks versus baseline ] [ Designated as safety issue: No ]

Enrollment: 115
Study Start Date: July 2006
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
For 3 weeks
 Drug: Zolpidem
Administration of Zolpidem 5mg

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00359229

Sponsors and Collaborators
Sanofi
Investigators
Study Director: Bruno Jolain Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00359229     History of Changes
Other Study ID Numbers: ZOLPI_L_01540
Study First Received: July 31, 2006
Last Updated: September 14, 2009
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Zolpidem
Hypnotics and Sedatives
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013