search
Back to results

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

Primary Purpose

Sleep Initiation and Maintenance Disorders

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Brotizolam
Estazolam
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Third Hospital of Beijing Hospital
  • Beijing Anding Hospital
  • Beijing Hospital
  • Peking Union Medical College Hospital
  • Guanzhou Psychiatric Hospital
  • Shanghai Mental Health Center
  • Hu Shan Hospital, Fu Dan University
  • Tongji Hospital, Tongji University

Outcomes

Primary Outcome Measures

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 Measures

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

Full Information

First Posted
June 30, 2006
Last Updated
December 27, 2017
Sponsor
Boehringer Ingelheim
search

1. Study Identification

Unique Protocol Identification Number
NCT00347295
Brief Title
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

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
253 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Brotizolam
Intervention Type
Drug
Intervention Name(s)
Estazolam
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
The Clinical Global Impression- Improvement score(CGI-I) The Clinical Global Impression- Severity score (CGI-S) Effective rate Rebound phenomena

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
Boehringer Ingelheim Shanghai
Official's Role
Study Chair
Facility Information:
Facility Name
Third Hospital of Beijing Hospital
City
Beijing
ZIP/Postal Code
100083
Country
China
Facility Name
Beijing Anding Hospital
City
Beijing
ZIP/Postal Code
100088
Country
China
Facility Name
Beijing Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Guanzhou Psychiatric Hospital
City
Guangzhou
ZIP/Postal Code
510370
Country
China
Facility Name
Shanghai Mental Health Center
City
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Hu Shan Hospital, Fu Dan University
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Tongji Hospital, Tongji University
City
Shanghai
ZIP/Postal Code
200065
Country
China

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/263/263.510_U10-3506.pdf
Description
Related Info
URL
https://www.ncbi.nlm.nih.gov/pubmed/23025837
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs