Randomised, Double-blind Study to Investigate the Safety and Efficacy of Brotizolam in Insomnia Outpatients.

Tracking Information
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; (submitted: June 30, 2006)	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; (submitted: June 30, 2006)	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
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
Condition ICMJE	Sleep Initiation and Maintenance Disorders
Intervention ICMJE	Drug: Brotizolam; Drug: Estazolam
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.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE; (submitted: October 31, 2013)	253
Original Enrollment ICMJE; (submitted: June 30, 2006)	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: Willing and able to provide written informed consent; Male or female, aged 18 - 65 (including 18 and 65); Diagnosed as insomnia by the criteria of CCMD-3: Exclusion_Criteria: Who received any central nervous system drugs within one week before visit 2(baseline); Continuous use of hypnotic agents for more than 3 months recently; History of inefficiency with benzodiazepine-type hypnotics; Who have a history of obvious hypersensitivity; Hamilton Depression Rating Scale (HAMD)18; Who was diagnosed with other mental illness; With serious diseases of heart, liver and kidney, etc; Who had sleep apnoea syndrome; Who had epileptic seizures within one year; With angle closure glaucoma that is acute or easy to occurred; Whose AST or ALT values are 2 times of normal upper limit; Whose Cr or BUN values are 2 times of normal upper limit; Who are known to be prone to the abuse of alcohol (i.e. history of evidence of acute or chronic abuse), or any other addictive agents; Who is participating in other clinical trial, or have participated in a clinical study of any other drug in one month prior to visit 2 (baseline). In addition, patients who has been randomized in this trial and then withdrew can not be enrolled again.; All pregnant, lactational women and women who have the plan of pregnancy.; Who are unwilling to or not able to complete the whole clinical trial; Other patients who are unsuitable to be included in the trial judged by investigator
Sex/Gender	Sexes Eligible for Study: All
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	Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim Shanghai
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