Skip to main content
OpenTrials
Completed

NCT Number: NCT00359229

Stilnox Treatment in Elderly Patients With Insomnia

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

zolpidem

Drug

Administration of Zolpidem 5mg

Primary outcomes

  1. Pittsburgh Sleep Quality Index (PSQI) score

    Time frame: At 1 week versus baseline

Secondary outcomes

  1. Pittsburgh Sleep Quality Index score

    Time frame: At 3 weeks versus baseline

  2. Subject sleeping efficacy variable

    Time frame: At 1 week and 3 weeks versus baseline

  3. Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale (HAMA) score

    Time frame: At 3 weeks versus baseline

  4. Adverse events (AE) and Serious adverse events (SAE) reports

    Time frame: Throughout the study period

  5. General Lab tests including hepatic and renal function

    Time frame: At 3 weeks versus baseline

  6. Vital signs

    Time frame: At 1 week and 3 weeks versus baseline

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Multicentre Prospective, Open Label ,3 Weeks Phase IV Study to Evaluate the Efficacy and Safety in Elder Patients With Insomnia in China

Acronym: STEP

Important dates

Study start
2006
Primary completion
2007
First posted
Aug 1, 2006
Registry last updated
Sep 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.