Randomised, Double-Blind Study to Investigate the Safety and Efficacy of Brotizolam in Insomnia Outpatients. - Full Text View

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00347295

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 III

Drug Information available for: Estazolam Brotizolam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

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:	240
Study Start Date:	June 2006
Estimated Study Completion Date:	January 2007

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

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

Locations

China
Shanghai Mental Health Center
Shanghai, China, 200030
Tongji Hospital, Tongji University
Shanghai, China, 200065
Hu Shan Hospital, Fu Dan University
Shanghai, China, 200040
Guanzhou Psychiatric Hospital
Guangzhou, China, 510370
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

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim Study Coordinator

Boehringer Ingelheim Shanghai

More Information

Study ID Numbers:	263.510
Study First Received:	June 30, 2006
Last Updated:	January 17, 2008
ClinicalTrials.gov Identifier:	NCT00347295
Health Authority:	P.R.China: SFDA

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders
Estazolam
Mental Disorders
Dyssomnias

Sleep Disorders
Brotizolam
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants

Pharmacologic Actions
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Anti-Anxiety Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 14, 2009