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

This study has been completed.

Sponsor:

Information provided by:

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT00347295

First received: June 30, 2006

Last updated: October 31, 2013

Last verified: October 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

June 30, 2006

Last Updated Date

October 31, 2013

Start Date ^ICMJE

June 2006

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

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

253

Estimated Completion Date

January 2007

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

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

October 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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