Randomised, Double-blind Study to Investigate the Safety and Efficacy of Brotizolam in Insomnia Outpatients.
- Conditions
- Sleep Initiation and Maintenance Disorders
- Registration Number
- NCT00347295
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To investigate the efficacy and safety of Brotizolam in the treatment of patients with insomnia in comparison with that of Estazolam
- Detailed Description
It is intended to recruit 240 insomnia outpatients in this study, 120 patients receiving Brotizolam + Estazolam placebo (Test Group) and 120 patients given Estazolam + Brotizolam placebo (Control Group).
Study Hypothesis:
Brotizolam can be safely used in insomnia patients in China. And Brotizolam 0.25mg is non-inferior with Estazolam 1-2mg in treatment of insomnia patients in China
Comparison(s):
Estazolam 1-2mg
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 253
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method change of Sleeping Dysfunction Rating Scale (SDRS) total score of Brotizolam in comparison with Estazolam after a 14-day oral administration in patients with insomnia.
- Secondary Outcome Measures
Name Time Method The Clinical Global Impression- Improvement score(CGI-I) The Clinical Global Impression- Severity score (CGI-S) Effective rate Rebound phenomena
Trial Locations
- Locations (8)
Beijing Hospital
🇨🇳Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, China
Shanghai Mental Health Center
🇨🇳Shanghai, China
Hu Shan Hospital, Fu Dan University
🇨🇳Shanghai, China
Tongji Hospital, Tongji University
🇨🇳Shanghai, China
Third Hospital of Beijing Hospital
🇨🇳Beijing, China
Guanzhou Psychiatric Hospital
🇨🇳Guangzhou, China
Beijing Anding Hospital
🇨🇳Beijing, China