Status:
COMPLETED
Randomised, Double-blind Study to Investigate the Safety and Efficacy of Brotizolam in Insomnia Outpatients.
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Sleep Initiation and Maintenance Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
To investigate the efficacy and safety of Brotizolam in the treatment of patients with insomnia in comparison with that of Estazolam
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 Grou...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
253 Patients enrolled
Trial Details
Trial ID
NCT00347295
Start Date
June 1 2006
End Date
January 1 2007
Last Update
December 28 2017
Active Locations (8)
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1
Third Hospital of Beijing Hospital
Beijing, China, 100083
2
Beijing Anding Hospital
Beijing, China, 100088
3
Beijing Hospital
Beijing, China, 100730
4
Peking Union Medical College Hospital
Beijing, China, 100730