Stilnox Treatment in Elderly Patients With Insomnia

Insomnia Clinical Trial

— STEP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00359229
• Other study ID #: ZOLPI_L_01540
• Status: Completed
• Phase: Phase 4
• First received: July 31, 2006
• Last updated: September 14, 2009
• Start date: July 2006

Study information

• Verified date: September 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia

Intervention

Drug:
• Zolpidem
Administration of Zolpidem 5mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pittsburgh Sleep Quality Index (PSQI) score		At 1 week versus baseline	No
Secondary	Pittsburgh Sleep Quality Index score		At 3 weeks versus baseline	No
Secondary	Subject sleeping efficacy variable		At 1 week and 3 weeks versus baseline	No
Secondary	Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale (HAMA) score		At 3 weeks versus baseline	No
Secondary	Adverse events (AE) and Serious adverse events (SAE) reports		Throughout the study period	Yes
Secondary	General Lab tests including hepatic and renal function		At 3 weeks versus baseline	No
Secondary	Vital signs		At 1 week and 3 weeks versus baseline	No