Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
---|---|
Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00347295 |
To investigate the efficacy and safety of Brotizolam in the treatment of patients with insomnia in comparison with that of Estazolam
Condition | Intervention | Phase |
---|---|---|
Sleep Initiation and Maintenance Disorders |
Drug: Brotizolam Drug: Estazolam |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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. |
Estimated Enrollment: | 240 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | January 2007 |
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
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion_Criteria:
Patients will be eligible for enrollment of this study if they meet all of the following criteria:
Exclusion_Criteria:
China | |
Shanghai Mental Health Center | |
Shanghai, China, 200030 | |
Tongji Hospital, Tongji University | |
Shanghai, China, 200065 | |
Hu Shan Hospital, Fu Dan University | |
Shanghai, China, 200040 | |
Guanzhou Psychiatric Hospital | |
Guangzhou, China, 510370 | |
Third Hospital of Beijing Hospital | |
Beijing, China, 100083 | |
Beijing Hospital | |
Beijing, China, 100730 | |
Peking Union Medical College Hospital | |
Beijing, China, 100730 | |
Beijing Anding Hospital | |
Beijing, China, 100088 |
Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim Shanghai |
Study ID Numbers: | 263.510 |
Study First Received: | June 30, 2006 |
Last Updated: | January 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00347295 |
Health Authority: | P.R.China: SFDA |
Sleep Initiation and Maintenance Disorders Estazolam Mental Disorders Dyssomnias |
Sleep Disorders Brotizolam Sleep Disorders, Intrinsic |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants |
Pharmacologic Actions Therapeutic Uses Hypnotics and Sedatives GABA Agents Anti-Anxiety Agents Central Nervous System Agents Anticonvulsants |