Randomised, Double-blind Study to Investigate the Safety and Efficacy of Brotizolam in Insomnia Outpatients.
NCT ID: NCT00347295
Last Updated: 2017-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
253 participants
INTERVENTIONAL
2006-06-30
2007-01-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Brotizolam
Estazolam
Eligibility Criteria
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Inclusion 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
18 Years
65 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Principal Investigators
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Boehringer Ingelheim Study Coordinator
Role: STUDY_CHAIR
Boehringer Ingelheim Shanghai
Locations
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Third Hospital of Beijing Hospital
Beijing, , China
Beijing Anding Hospital
Beijing, , China
Beijing Hospital
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
Guanzhou Psychiatric Hospital
Guangzhou, , China
Shanghai Mental Health Center
Shanghai, , China
Hu Shan Hospital, Fu Dan University
Shanghai, , China
Tongji Hospital, Tongji University
Shanghai, , China
Countries
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Related Links
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Related Info
Other Identifiers
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263.510
Identifier Type: -
Identifier Source: org_study_id