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

NCT00347295 | Completed Phase 3

• 1 other identifier: 263.510
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Sleep Initiation and Maintenance Disorders

Outcome Measures

Primary Outcomes (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 Outcomes (1)

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

Interventions

Brotizolam DRUG

Estazolam DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (8)

Third Hospital of Beijing Hospital

Beijing, 100083, China

Location

Beijing Anding Hospital

Beijing, 100088, China

Location

Beijing Hospital

Beijing, 100730, China

Location

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Guanzhou Psychiatric Hospital

Guangzhou, 510370, China

Location

Shanghai Mental Health Center

Shanghai, 200030, China

Location

Hu Shan Hospital, Fu Dan University

Shanghai, 200040, China

Location

Tongji Hospital, Tongji University

Shanghai, 200065, China

Location

Related Links

• Related Info

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

brotizolam; Estazolam

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Boehringer Ingelheim Study Coordinator

  Boehringer Ingelheim Shanghai

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 30, 2006
• First Posted: July 4, 2006
• Study Start: June 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: December 28, 2017

Record last verified: 2017-12

Locations

CN (8)