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

Condition(s) targeted: Sleep Initiation and Maintenance Disorders

Intervention: Brotizolam (Drug); Estazolam (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Boehringer Ingelheim Pharmaceuticals

Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: Boehringer Ingelheim Shanghai

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

Official title: 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 design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

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

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Shanghai Mental Health Center, Shanghai 200030, China

Tongji Hospital, Tongji University, Shanghai 200065, China

Hu Shan Hospital, Fu Dan University, Shanghai 200040, China

Guanzhou Psychiatric Hospital, Guangzhou 510370, China

Beijing Anding Hospital, Beijing 100088, China

Beijing Hospital, Beijing 100730, China

Peking Union Medical College Hospital, Beijing 100730, China

Third Hospital of Beijing Hospital, Beijing 100083, China

Starting date: June 2006
Ending date: January 2007
Last updated: January 17, 2008