Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
Study NCT ID:
NCT04161768
Status:
RECRUITING
Last Update Posted:
2019-11-13
First Post:
2019-11-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Norfloxacin With Itopride Versus Norfloxacin in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009643', 'term': 'Norfloxacin'}, {'id': 'C102254', 'term': 'itopride'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2028-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-10', 'studyFirstSubmitDate': '2019-11-10', 'studyFirstSubmitQcDate': '2019-11-10', 'lastUpdatePostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of bouts of recurrence during treatment.', 'timeFrame': '6 months', 'description': 'The recurrence of infection during treatment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spontaneous Bacterial Peritonitis']}, 'descriptionModule': {'briefSummary': 'Norfloxacin versus Norfloxacin with Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis', 'detailedDescription': 'Comparative Study of Norfloxacin versus Norfloxacin with Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cirrhotic patients with ascites who had previous episodes of SBP.\n\nExclusion Criteria:\n\n* 1\\. Allergy or contraindication for the used drugs. 2. Recent antibiotics therapy in the previous 2 weeks. 3. Patients with hepatocellular carcinoma or other neoplasia. 4. Pregnant and lactating women.'}, 'identificationModule': {'nctId': 'NCT04161768', 'briefTitle': 'Norfloxacin With Itopride Versus Norfloxacin in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Comparative Study of Norfloxacin Versus Norfloxacin With Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis', 'orgStudyIdInfo': {'id': 'SBP Management'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Norfloxacin', 'description': 'Norfloxacin 400 mg daily', 'interventionNames': ['Drug: Norfloxacin']}, {'type': 'EXPERIMENTAL', 'label': 'Norfloxacin and Itopride', 'description': 'Norfloxacin 400 mg daily and Itopride 50 mg three times daily.', 'interventionNames': ['Drug: Norfloxacin', 'Drug: Itopride']}], 'interventions': [{'name': 'Norfloxacin', 'type': 'DRUG', 'otherNames': ['Epinor'], 'description': 'Norfloxacin 400 mg daily', 'armGroupLabels': ['Norfloxacin', 'Norfloxacin and Itopride']}, {'name': 'Itopride', 'type': 'DRUG', 'otherNames': ['Ganaton'], 'description': 'Itopride 50 mg three times daily', 'armGroupLabels': ['Norfloxacin and Itopride']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Sherief Abd-Elsalam', 'role': 'CONTACT'}], 'facility': 'Sherief Abd-Elsalam', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Sherief Abd-Elsalam, ass. prof.', 'role': 'CONTACT', 'email': 'sheriefabdelsalam@yahoo.com', 'phone': '00201147773440'}, {'name': 'sherief abd-elsalam, ass. prof.', 'role': 'CONTACT', 'email': 'sherif_tropical@yahoo.com', 'phone': '00201147773440'}], 'overallOfficials': [{'name': 'Afaf Younes Mohammed Younes, Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tanta University - Faculty of Medicine'}, {'name': 'Mona Ahmed Helmy Shehata, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tanta University - Faculty of Medicine'}, {'name': 'Sherief Abd-Elsalam, Ass. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tanta University - Tropical Medicine Department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ass. Prof. Tropical Medicine', 'investigatorFullName': 'Sherief Abd-Elsalam', 'investigatorAffiliation': 'Tanta University'}}}}