Clinical trial NCT00359229: Stilnox Treatment in Elderly Patients With Insomnia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Insomnia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-08-01
Enrollment: 115
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI) score
timeFrame: At 1 week versus baseline
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index score
timeFrame: At 3 weeks versus baseline
measure: Subject sleeping efficacy variable
timeFrame: At 1 week and 3 weeks versus baseline
measure: Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale (HAMA) score
timeFrame: At 3 weeks versus baseline
measure: Adverse events (AE) and Serious adverse events (SAE) reports
timeFrame: Throughout the study period
measure: General Lab tests including hepatic and renal function
timeFrame: At 3 weeks versus baseline
measure: Vital signs
timeFrame: At 1 week and 3 weeks versus baseline
Other outcomes:
Locations:
Study officials:
affiliation: Sanofi
name: Bruno Jolain
role: STUDY_DIRECTOR
References: