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

Boehringer Ingelheim

Status and phase

Completed

Phase 3

Conditions

Sleep Initiation and Maintenance Disorders

Treatments

Drug: Brotizolam

Drug: Estazolam

Study type

Interventional

Funder types

Industry

Identifiers

NCT00347295

263.510

Details and patient eligibility

About

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

Full 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

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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