Randomised, Double-blind Study to Investigate the Safety and Efficacy of Brotizolam in Insomnia Outpatients.
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ClinicalTrials.gov Identifier: NCT00347295 |
Recruitment Status
:
Completed
First Posted
: July 4, 2006
Last Update Posted
: December 28, 2017
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Sponsor:
Boehringer Ingelheim
Information provided by:
Boehringer Ingelheim
Tracking Information | ||||
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First Submitted Date ICMJE | June 30, 2006 | |||
First Posted Date ICMJE | July 4, 2006 | |||
Last Update Posted Date | December 28, 2017 | |||
Study Start Date ICMJE | June 2006 | |||
Actual Primary Completion Date | January 2007 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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. | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00347295 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
The Clinical Global Impression- Improvement score(CGI-I) The Clinical Global Impression- Severity score (CGI-S) Effective rate Rebound phenomena | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Randomised, Double-blind Study to Investigate the Safety and Efficacy of Brotizolam in Insomnia Outpatients. | |||
Official Title ICMJE | 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. | |||
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 |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment |
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Condition ICMJE | Sleep Initiation and Maintenance Disorders | |||
Intervention ICMJE |
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Study Arms | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE |
253 | |||
Original Enrollment ICMJE |
240 | |||
Study Completion Date | January 2007 | |||
Actual Primary Completion Date | January 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion_Criteria: Patients will be eligible for enrollment of this study if they meet all of the following criteria:
Exclusion_Criteria:
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Sex/Gender |
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Ages | 18 Years to 65 Years (Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | China | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00347295 | |||
Other Study ID Numbers ICMJE | 263.510 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Boehringer Ingelheim | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Boehringer Ingelheim | |||
Verification Date | December 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |