Clinical trial NCT00347295: Randomised, Double-blind Study to Investigate the Safety and Efficacy of Brotizolam in Insomnia Outpatients.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sleep Initiation and Maintenance Disorders
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2006-07-04
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Eligibility 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

Primary outcomes:
measure: 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:
measure: The Clinical Global Impression- Improvement score(CGI-I) The Clinical Global Impression- Severity score (CGI-S) Effective rate Rebound phenomena
Other outcomes:
Locations:
city: Beijing
country: China
facility: Third Hospital of Beijing Hospital
city: Beijing
country: China
facility: Beijing Anding Hospital
city: Beijing
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Guangzhou
country: China
facility: Guanzhou Psychiatric Hospital
city: Shanghai
country: China
facility: Shanghai Mental Health Center
city: Shanghai
country: China
facility: Hu Shan Hospital, Fu Dan University
city: Shanghai
country: China
facility: Tongji Hospital, Tongji University
Study officials:
affiliation: Boehringer Ingelheim Shanghai
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: