Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-28 @ 3:08 AM
Study NCT ID:
NCT00889356
Status:
UNKNOWN
Last Update Posted:
2009-04-28
First Post:
2009-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin and Ketoconazole for the Treatment of Mixed-Type Vaginosis, Bacterial Vaginosis and Candidiasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D016585', 'term': 'Vaginosis, Bacterial'}], 'ancestors': [{'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D014627', 'term': 'Vaginitis'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002981', 'term': 'Clindamycin'}, {'id': 'D007654', 'term': 'Ketoconazole'}, {'id': 'D013752', 'term': 'Tetracycline'}, {'id': 'D000666', 'term': 'Amphotericin B'}], 'ancestors': [{'id': 'D008034', 'term': 'Lincomycin'}, {'id': 'D055231', 'term': 'Lincosamides'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2010-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-04-27', 'studyFirstSubmitDate': '2009-04-24', 'studyFirstSubmitQcDate': '2009-04-27', 'lastUpdatePostDateStruct': {'date': '2009-04-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy based on cure rate evaluated by clinical and laboratory criteria.', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': "Tolerability based on adverse events reports and patient's information", 'timeFrame': '7 days'}, {'measure': 'Safety based on adverse events reports and laboratory criterion', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Candidiasis', 'Bacterial Vaginosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the Efficacy, Tolerability \\& Safety of Combination of Clindamycin 100mg and Ketoconazole 400mg in Vaginal Capsules, used for 7 consecutive days in patients with Mixed-Type Vaginosis compared to Combination of Tetracycline 100mg and Amphotericin B 50mg in Vaginal Cream.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mixed-type vaginosis\n* Bacterial vaginosis\n* Candidiasis\n\nExclusion Criteria:\n\n* Pregnancy\n* Vaginal bleeding\n* History of recurrent vaginosis'}, 'identificationModule': {'nctId': 'NCT00889356', 'briefTitle': 'Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin and Ketoconazole for the Treatment of Mixed-Type Vaginosis, Bacterial Vaginosis and Candidiasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zodiac Produtos Farmaceuticos S.A.'}, 'officialTitle': 'Phase III, Open Label, Randomized, Multicenter Study to Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin 100mg and Ketoconazole 400mg in Vaginal Capsules, Compared to Combination of Tetracycline 100mg and Amphotericin B 50mg in Vaginal Cream for the Treatment of Bacterial Vaginosis and Candidiasis Isolatedly or in Association (Mixed-Type Vaginosis)', 'orgStudyIdInfo': {'id': 'ZD 002-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clindamycin 100mg and Ketoconazole 400mg', 'interventionNames': ['Drug: Clindamycin 100mg and Ketoconazole 400mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tetracycline 100mg and Amphotericin B 50mg', 'interventionNames': ['Drug: Tetracycline 100mg and Amphotericin B 50mg']}], 'interventions': [{'name': 'Clindamycin 100mg and Ketoconazole 400mg', 'type': 'DRUG', 'description': '1 vaginal capsule once a day at night', 'armGroupLabels': ['Clindamycin 100mg and Ketoconazole 400mg']}, {'name': 'Tetracycline 100mg and Amphotericin B 50mg', 'type': 'DRUG', 'description': 'One full applicator, once a day at night', 'armGroupLabels': ['Tetracycline 100mg and Amphotericin B 50mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jundiaí', 'state': 'São Paulo', 'country': 'Brazil', 'contacts': [{'name': 'Rogerio Bonassi Machado, MD', 'role': 'CONTACT'}, {'name': 'Rogerio Bonassi Machado, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vox Femina', 'geoPoint': {'lat': -23.18639, 'lon': -46.88417}}], 'centralContacts': [{'name': 'Rogerio Bonassi Machado, MD', 'role': 'CONTACT', 'email': 'rogeriobonassi@terra.com.br', 'phone': '+55 11 4521-6466'}, {'name': 'Paula Fabrini, MD', 'role': 'CONTACT', 'phone': '+55 11 4521-6466'}], 'overallOfficials': [{'name': 'Rogerio Bonassi Machado, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CRM Regional Council of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zodiac Produtos Farmaceuticos S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Julio Cesar Nophal de Carvalho', 'oldOrganization': 'Zodiac Produtos Farmaceuticos'}}}}