Ignite Creation Date:
2025-12-24 @ 2:10 PM
Ignite Modification Date:
2025-12-25 @ 12:50 PM
Study NCT ID:
NCT00347295
Status:
COMPLETED
Last Update Posted:
2017-12-28
First Post:
2006-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomised, Double-blind Study to Investigate the Safety and Efficacy of Brotizolam in Insomnia Outpatients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C020960', 'term': 'brotizolam'}, {'id': 'D004949', 'term': 'Estazolam'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 253}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2007-01'}, 'lastUpdateSubmitDate': '2017-12-27', 'studyFirstSubmitDate': '2006-06-30', 'studyFirstSubmitQcDate': '2006-06-30', 'lastUpdatePostDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.'}], 'secondaryOutcomes': [{'measure': 'The Clinical Global Impression- Improvement score(CGI-I) The Clinical Global Impression- Severity score (CGI-S) Effective rate Rebound phenomena'}]}, 'conditionsModule': {'conditions': ['Sleep Initiation and Maintenance Disorders']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/23025837', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'To investigate the efficacy and safety of Brotizolam in the treatment of patients with insomnia in comparison with that of Estazolam', 'detailedDescription': '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).\n\nStudy Hypothesis:\n\nBrotizolam 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\n\nComparison(s):\n\nEstazolam 1-2mg'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion\\_Criteria:\n\nPatients will be eligible for enrollment of this study if they meet all of the following criteria:\n\n* Willing and able to provide written informed consent\n* Male or female, aged 18 - 65 (including 18 and 65)\n* Diagnosed as insomnia by the criteria of CCMD-3:\n\nExclusion\\_Criteria:\n\n* Who received any central nervous system drugs within one week before visit 2(baseline)\n* Continuous use of hypnotic agents for more than 3 months recently\n* History of inefficiency with benzodiazepine-type hypnotics\n* Who have a history of obvious hypersensitivity\n* Hamilton Depression Rating Scale (HAMD)18\n* Who was diagnosed with other mental illness\n* With serious diseases of heart, liver and kidney, etc\n* Who had sleep apnoea syndrome\n* Who had epileptic seizures within one year\n* With angle closure glaucoma that is acute or easy to occurred\n* Whose AST or ALT values are 2 times of normal upper limit\n* Whose Cr or BUN values are 2 times of normal upper limit\n* 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\n* 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.\n* All pregnant, lactational women and women who have the plan of pregnancy.\n* Who are unwilling to or not able to complete the whole clinical trial\n* Other patients who are unsuitable to be included in the trial judged by investigator'}, 'identificationModule': {'nctId': 'NCT00347295', 'briefTitle': 'Randomised, Double-blind Study to Investigate the Safety and Efficacy of Brotizolam in Insomnia Outpatients.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': '263.510'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Brotizolam', 'type': 'DRUG'}, {'name': 'Estazolam', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100083', 'city': 'Beijing', 'country': 'China', 'facility': 'Third Hospital of Beijing Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100088', 'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Anding Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100730', 'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100730', 'city': 'Beijing', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '510370', 'city': 'Guangzhou', 'country': 'China', 'facility': 'Guanzhou Psychiatric Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '200030', 'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Mental Health Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200040', 'city': 'Shanghai', 'country': 'China', 'facility': 'Hu Shan Hospital, Fu Dan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200065', 'city': 'Shanghai', 'country': 'China', 'facility': 'Tongji Hospital, Tongji University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim Study Coordinator', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim Shanghai'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}}}}