Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-25 @ 5:31 PM
Study NCT ID:
NCT05553704
Status:
COMPLETED
Last Update Posted:
2025-04-08
First Post:
2022-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metformin in Patients With Ulcerative Colitis Treated With Mesalamine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-05', 'studyFirstSubmitDate': '2022-09-20', 'studyFirstSubmitQcDate': '2022-09-21', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint is the change in partial mayo score index', 'timeFrame': '6 months', 'description': "The Partial Mayo Score index is a non-invasive clinical scale used to assess the severity of ulcerative colitis. It is a composite of sub scores from three categories, including stool frequency, rectal bleeding, and physician's global assessment, with a total score ranging from 0-9"}], 'secondaryOutcomes': [{'measure': 'The secondary endpoint is estimated by changes in serum IL-6 and TNF-alpha', 'timeFrame': '6 months', 'description': 'The secondary endpoint is estimated by changes in serum IL-6 and TNF-alpha'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Diseases']}, 'referencesModule': {'references': [{'pmid': '40191419', 'type': 'DERIVED', 'citation': 'Binsaleh AY, El-Haggar SM, Hegazy SK, Maher MM, Bahgat MM, Elmasry TA, Alrubia S, Alsegiani AS, Eldesoqui M, Bahaa MM. The adjunctive role of metformin in patients with mild to moderate ulcerative colitis: a randomized controlled study. Front Pharmacol. 2025 Mar 19;16:1507009. doi: 10.3389/fphar.2025.1507009. eCollection 2025.'}, {'pmid': '38917525', 'type': 'DERIVED', 'citation': 'El-Haggar SM, Hegazy SK, Maher MM, Bahgat MM, Bahaa MM. Repurposing metformin as adjuvant therapy in patients with ulcerative colitis treated with mesalamine: A randomized controlled double-blinded study. Int Immunopharmacol. 2024 Sep 10;138:112541. doi: 10.1016/j.intimp.2024.112541. Epub 2024 Jun 24.'}]}, 'descriptionModule': {'briefSummary': 'Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease characterized by diffused inflammation of the colon and rectum mucosa, however, the exact underlying mechanisms of UC remain poorly understood.UC is strongly dependent on cellular immune reaction and exaggerated inflammatory response due to genetic, immune and environmental factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Both males and females will be included\n* Negative pregnancy test and effective contraception\n\nExclusion Criteria:\n\n* •\n\n * Breast feeding\n * Significant liver and kidney function abnormalities\n * Diabetic patients\n * Colorectal cancer patients\n * Patients with severe UC\n * Patients taking rectal or systemic steroids\n * Patients taking immunosuppressives or biological therapies\n * Addiction to alcohol and / or drugs\n * Known allergy to the studied medications'}, 'identificationModule': {'nctId': 'NCT05553704', 'briefTitle': 'Metformin in Patients With Ulcerative Colitis Treated With Mesalamine', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Clinical Study to Compare the Possible Efficacy of Metformin in Patients With Ulcerative Colitis Treated With Mesalamine', 'orgStudyIdInfo': {'id': '3422'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'this group will take mesalamine 1 gm three times daily for 6 months'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'metformin group', 'description': 'this group will take mesalamine 1 gm three times daily plus metformin 500 mg two times daily for 6 months', 'interventionNames': ['Drug: Metformin']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'description': 'metformin group will take mesalamine 1 gm three times daily plus metformin 500 mg two times daily', 'armGroupLabels': ['metformin group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35511', 'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Faculty of Medicine, Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mounir Hussein Bahgat Internal Medicine Department Mansoura University', 'class': 'UNKNOWN'}, {'name': 'Maha Mohamed Maher Internal Medicine Department Mansoura University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Teaching Assistant', 'investigatorFullName': 'Mostafa Bahaa', 'investigatorAffiliation': 'Tanta University'}}}}