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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00347295
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : December 28, 2017
Information provided by:
Boehringer Ingelheim

Brief Summary:
To investigate the efficacy and safety of Brotizolam in the treatment of patients with insomnia in comparison with that of Estazolam

Condition or disease Intervention/treatment Phase
Sleep Initiation and Maintenance Disorders Drug: Brotizolam Drug: Estazolam Phase 3

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


Estazolam 1-2mg

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Study Type : Interventional  (Clinical Trial)
Enrollment : 253 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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.
Study Start Date : June 2006
Actual Primary Completion Date : January 2007
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Estazolam

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. The Clinical Global Impression- Improvement score(CGI-I) The Clinical Global Impression- Severity score (CGI-S) Effective rate Rebound phenomena

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


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:


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00347295

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Third Hospital of Beijing Hospital
Beijing, China, 100083
Beijing Anding Hospital
Beijing, China, 100088
Beijing Hospital
Beijing, China, 100730
Peking Union Medical College Hospital
Beijing, China, 100730
Guanzhou Psychiatric Hospital
Guangzhou, China, 510370
Shanghai Mental Health Center
Shanghai, China, 200030
Hu Shan Hospital, Fu Dan University
Shanghai, China, 200040
Tongji Hospital, Tongji University
Shanghai, China, 200065
Sponsors and Collaborators
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim Shanghai
Additional Information:
Layout table for additonal information Identifier: NCT00347295    
Other Study ID Numbers: 263.510
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: December 28, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action