- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00347295
Randomised, Double-blind Study to Investigate the Safety and Efficacy of Brotizolam in Insomnia Outpatients.
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 Overview
Status
Conditions
Intervention / Treatment
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
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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Beijing, China, 100730
- Beijing Hospital
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Beijing, China, 100730
- Peking Union Medical College Hospital
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Beijing, China, 100083
- Third Hospital of Beijing Hospital
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Beijing, China, 100088
- Beijing Anding Hospital
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Guangzhou, China, 510370
- Guanzhou Psychiatric Hospital
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Shanghai, China, 200065
- Tongji Hospital, Tongji University
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Shanghai, China, 200030
- Shanghai Mental Health Center
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Shanghai, China, 200040
- Hu Shan Hospital, Fu Dan University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Secondary Outcome Measures
Outcome Measure |
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The Clinical Global Impression- Improvement score(CGI-I) The Clinical Global Impression- Severity score (CGI-S) Effective rate Rebound phenomena
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Boehringer Ingelheim Study Coordinator, Boehringer Ingelheim Shanghai
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Sleep Initiation and Maintenance Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Anticonvulsants
- Brotizolam
- Estazolam
Other Study ID Numbers
- 263.510
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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