Randomised, Double-blind Study to Investigate the Safety... | NCT00347295

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

NCT00347295

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Dec 28, 2017Actual

Enrollment

253

Phase

Phase 3

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Brotizolam
Estazolam

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Jan 2007Actual

Completion Date

Jan 2007

First Submitted Date

Jun 30, 2006

First Submission Date that Met QC Criteria

Jun 30, 2006

First Posted Date

Jul 4, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 27, 2017

Last Update Posted Date

Dec 28, 2017Actual

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

253

Outcomes Module

Primary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Brotizolam	Drug
Estazolam	Drug

Facility	Status	City	State	ZIP	Country	Contacts
Third Hospital of Beijing Hospital		Beijing		100083	China
Beijing Anding Hospital

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

ID	Term
C020960	brotizolam
D004949	Estazolam

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring