Trials / Completed
CompletedNCT00347295
Randomised, Double-blind Study to Investigate the Safety and Efficacy of Brotizolam in Insomnia Outpatients.
A Randomised, Double-blinded, Double-dummy, Multi-center, Paralleled Study to Investigate the Safety and Efficacy of Brotizolam (Lendormin) Compared With Estazolam in Insomnia Outpatients.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 253 (planned)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Brotizolam | |
| DRUG | Estazolam |
Timeline
- Start date
- 2006-06-01
- Primary completion
- 2007-01-01
- Completion
- 2007-01-01
- First posted
- 2006-07-04
- Last updated
- 2017-12-28
Locations
8 sites across 1 country: China
Source: ClinicalTrials.gov record NCT00347295. Inclusion in this directory is not an endorsement.