Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2026-02-21 @ 1:36 AM
Study NCT ID:
NCT01733966
Status:
TERMINATED
Last Update Posted:
2018-09-17
First Post:
2012-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicentre, Randomized as a Double Blind Study, Triple Placebo, Comparative of the Efficacy and Safety of an Association Secnidazol-Ciprofloxacin Compared With Amoxicillin-Clavulanic Acid for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C016724', 'term': 'secnidazole'}, {'id': 'D002939', 'term': 'Ciprofloxacin'}, {'id': 'D019980', 'term': 'Amoxicillin-Potassium Clavulanate Combination'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019818', 'term': 'Clavulanic Acid'}, {'id': 'D002969', 'term': 'Clavulanic Acids'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'whyStopped': 'difficulties to recruit patients who suffer from this pathology', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-13', 'studyFirstSubmitDate': '2012-11-21', 'studyFirstSubmitQcDate': '2012-11-21', 'lastUpdatePostDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparaison of the efficacy of an association of Secnidazol(2g)-Ciprofloxacin(1g) (during 3 days) versus 3g of Amoxicillin-Clavulanic Acid during 10 days for clinical and biological cure', 'timeFrame': 'the cure rate will be evaluated at the second visit (14 days after the inclusion visit)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diverticular Sigmoïditis']}, 'descriptionModule': {'briefSummary': 'The primary outcome measure is to compare efficacy of an association of Secnidazol(2g)-Ciprofloxacin(1g) (during 3 days) versus 3g of Amoxicillin-Clavulanic Acid during 10 days for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among Adults in clinical and biological cure.\n\nThe cure rate will be evaluated at the second visit (14 days after the inclusion visit)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult\n* Recovering of written and dated informed consent form\n* Social Security medical cover\n* Left Iliac Fossa (LIF) pain\n* Moderate fever (\\>37.8°C)\n* Sensitivity/defence during LIF palpation\n\nBiological results :\n\n* CRP \\> 10mg/L\n* NFS \\> 10G/L\n* Neutrophil Granulocytosis \\> 75%\n* Radiological results - presence to the scan :diverticul \\& pericolic infiltration\n\nExclusion Criteria:\n\n* Patients treated by antibiotherapy in the last 15 days prior inclusion\n* Patients treated by morphinic drug\n* Patients treated by anticoagulant drug\n* Pregnant or breast-feeding women\n* Patients presenting allergy to active principal, to galactose\n* Patients having taking part in another study in the last 3 months prior inclusion\n* Patients unable to comply with the study requirements\n* Patients presenting Chronic affection inconsistent with the study\n* Patients presenting high fever\n* Patients presenting abdominal contracture\n* Patients presenting immunosuppression\n* Radiological sign of complication (abscess\\>3cm)\n* Patients presenting Pathology inconsistent with efficacy evaluatio'}, 'identificationModule': {'nctId': 'NCT01733966', 'acronym': 'DIVA', 'briefTitle': 'A Multicentre, Randomized as a Double Blind Study, Triple Placebo, Comparative of the Efficacy and Safety of an Association Secnidazol-Ciprofloxacin Compared With Amoxicillin-Clavulanic Acid for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among Adults', 'nctIdAliases': ['NCT01136434'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Quanta Medical'}, 'officialTitle': 'A Third Phase, Multicentre, Randomized as a Double Blind Study, Triple Placebo, Comparative of the Efficacy and Safety of an Association Secnidazol-Ciprofloxacin Compared With Amoxicillin-Clavulanic Acid for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among Adults', 'orgStudyIdInfo': {'id': 'IPR_SIGMO_09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Secnidazol-Ciprofloxacin', 'description': '2g(single dose) of Secnidazol associated with 1g(2 doses of 500mg)of Ciprofloxacin during 3 days', 'interventionNames': ['Drug: Secnidazole, ciprofloxacine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Amoxicillin-Clavulanic Acid', 'description': '3g (3 doses of 1g) of Amoxicillin-Clavulanic acid during 10 days', 'interventionNames': ['Drug: Amoxicillin-Clavulanic Acid']}], 'interventions': [{'name': 'Secnidazole, ciprofloxacine', 'type': 'DRUG', 'description': '2g of microgranules of secnidazole. a single dose per day during 3 days.\n\n1g of Ciprofloxacin (2 tablets of 500mg per day during 3 days)', 'armGroupLabels': ['Secnidazol-Ciprofloxacin']}, {'name': 'Amoxicillin-Clavulanic Acid', 'type': 'DRUG', 'description': '3g of Amoxicillin-Clavulanic acid (3 powder packet of 1g per day during 10 days)', 'armGroupLabels': ['Amoxicillin-Clavulanic Acid']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Quanta Medical', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Laboratoires Iprad-Vegebom', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}