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
  Purpose

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

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

Estimated Enrollment: 253
Study Start Date: June 2006
Estimated Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00347295

Locations
China
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
Guanzhou Psychiatric Hospital
Guangzhou, China, 510370
Shanghai Mental Health Center
Shanghai, China, 200030
Tongji Hospital, Tongji University
Shanghai, China, 200065
Hu Shan Hospital, Fu Dan University
Shanghai, China, 200040
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim Shanghai
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00347295     History of Changes
Other Study ID Numbers: 263.510
Study First Received: June 30, 2006
Last Updated: October 31, 2013
Health Authority: P.R.China: SFDA

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Estazolam
Brotizolam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on August 01, 2014