Randomised, Double-blind Study to Investigate the Safety and Efficacy of Brotizolam in Insomnia Outpatients.
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00347295
First received: June 30, 2006
Last updated: May 18, 2012
Last verified: May 2012
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Purpose
To investigate the efficacy and safety of Brotizolam in the treatment of patients with insomnia in comparison with that of Estazolam
| Condition | Intervention | Phase |
|---|---|---|
|
Sleep Initiation and Maintenance Disorders |
Drug: Brotizolam Drug: Estazolam |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
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
| Estimated Enrollment: | 240 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | January 2007 |
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00347295
Locations
| China | |
| Third Hospital of Beijing Hospital | |
| Beijing, China, 100083 | |
| Beijing Hospital | |
| Beijing, China, 100730 | |
| Peking Union Medical College Hospital | |
| Beijing, China, 100730 | |
| Beijing Anding Hospital | |
| Beijing, China, 100088 | |
| Guanzhou Psychiatric Hospital | |
| Guangzhou, China, 510370 | |
| Shanghai Mental Health Center | |
| Shanghai, China, 200030 | |
| Tongji Hospital, Tongji University | |
| Shanghai, China, 200065 | |
| Hu Shan Hospital, Fu Dan University | |
| Shanghai, China, 200040 | |
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim Shanghai |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00347295 History of Changes |
| Other Study ID Numbers: | 263.510 |
| Study First Received: | June 30, 2006 |
| Last Updated: | May 18, 2012 |
| Health Authority: | P.R.China: SFDA |
Additional relevant MeSH terms:
|
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Mental Disorders Estazolam Brotizolam Anticonvulsants Central Nervous System Agents Therapeutic Uses |
Pharmacologic Actions Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hypnotics and Sedatives |
ClinicalTrials.gov processed this record on June 18, 2013