Overview

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

Status:
Completed
Trial end date:
2007-01-01
Target enrollment:
0
Participant gender:
All
Summary
To investigate the efficacy and safety of Brotizolam in the treatment of patients with insomnia in comparison with that of Estazolam
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Boehringer Ingelheim
Treatments:
Brotizolam
Estazolam
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