Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-25 @ 7:52 PM
Study NCT ID:
NCT04750135
Status:
UNKNOWN
Last Update Posted:
2021-02-11
First Post:
2021-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003108', 'term': 'Colonic 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', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-02-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-07', 'studyFirstSubmitDate': '2021-02-07', 'studyFirstSubmitQcDate': '2021-02-07', 'lastUpdatePostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference between the two groups in the expression of colonic (NF)-κB proteins.', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ulcerative Colitis', 'Inflammatory Bowel Diseases']}, 'referencesModule': {'references': [{'pmid': '20806430', 'type': 'BACKGROUND', 'citation': 'Hegazy SK, El-Bedewy MM. Effect of probiotics on pro-inflammatory cytokines and NF-kappaB activation in ulcerative colitis. World J Gastroenterol. 2010 Sep 7;16(33):4145-51. doi: 10.3748/wjg.v16.i33.4145.'}, {'pmid': '18325386', 'type': 'BACKGROUND', 'citation': 'Lewis JD, Lichtenstein GR, Deren JJ, Sands BE, Hanauer SB, Katz JA, Lashner B, Present DH, Chuai S, Ellenberg JH, Nessel L, Wu GD; Rosiglitazone for Ulcerative Colitis Study Group. Rosiglitazone for active ulcerative colitis: a randomized placebo-controlled trial. Gastroenterology. 2008 Mar;134(3):688-95. doi: 10.1053/j.gastro.2007.12.012. Epub 2007 Dec 7.'}, {'pmid': '29653414', 'type': 'BACKGROUND', 'citation': 'Samman FS, Elaidy SM, Essawy SS, Hassan MS. New insights on the modulatory roles of metformin or alpha-lipoic acid versus their combination in dextran sulfate sodium-induced chronic colitis in rats. Pharmacol Rep. 2018 Jun;70(3):488-496. doi: 10.1016/j.pharep.2017.11.015. Epub 2017 Nov 24.'}]}, 'descriptionModule': {'briefSummary': 'Brief Summary:\n\nThis is a randomized, controlled study evaluating metformin tablets administered daily for 8 weeks. The purpose of the study is to evaluate the efficacy and safety of metformin in the treatment of mild to moderately active ulcerative colitis. Disease activity will be measured using Mayo score for ulcerative colitis activity. Calculation of the score requires patients to undergo colonoscopy at the start of the study and at week 8.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with mild or moderate ulcerative colitis newly diagnosed by colonoscopy and biopsy according to Mayo endoscopic scoring of ulcerative colitis.\n2. Adults (males and/or females) with age range from 18 to 65 years old.\n3. Patients on treatment with 5-aminosalisylic acid (5-ASA)\n\nExclusion Criteria:\n\n1. Patients with severe ulcerative colitis according to Mayo endoscopic scoring of ulcerative colitis.\n2. Treatment with systemic or rectal steroids.\n3. Treatment with immunosuppressants.\n4. Previously failed treatment with a sulphasalazine.\n5. Known hypersensitivity to any of study drugs.\n6. Hepatic and renal dysfunction.\n7. Pregnancy and lactation.\n8. History of colorectal carcinoma.\n9. History of complete or partial colectomy.\n10. Current or previous treatment with metformin for females with polycystic ovarian syndrome.\n11. Patients with diabetes mellitus\n12. Patients with history of lactic acidosis\n13. Patients with disease states associated with hypoxemia including cardiorespiratory insufficiency\n14. Positive stool culture for enteric pathogens, positive stool ova and parasite exam.'}, 'identificationModule': {'nctId': 'NCT04750135', 'briefTitle': 'Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Hepatology & Tropical Medicine Research Institute'}, 'officialTitle': 'Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis', 'orgStudyIdInfo': {'id': '21-2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'participants will receive placebo for 8 consecutive weeks in addition to the standard therapy', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Metformin group', 'description': 'participants will receive 500 mg Metformin TID for 8 consecutive weeks in addition to the standard therapy', 'interventionNames': ['Drug: metformin 500 mg TID Oral Tablet']}], 'interventions': [{'name': 'metformin 500 mg TID Oral Tablet', 'type': 'DRUG', 'otherNames': ['Glucophage XR'], 'description': 'biguanides derivatives', 'armGroupLabels': ['Metformin group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'state': 'Gharbia Governorate', 'country': 'Egypt', 'contacts': [{'name': 'Nahla Khalaf, MD', 'role': 'CONTACT'}, {'name': 'MD', 'role': 'CONTACT'}, {'name': 'Fatma elgebaly, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Fatma Khairy, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nahla Khalaf, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Tanta University Hospitals', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Doaa Hamed, PhD', 'role': 'CONTACT', 'email': 'Abdelaziz.h.doaa@gmail.com', 'phone': '+202 23642494'}], 'overallOfficials': [{'name': 'Noha Mansour, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Hepatology & Tropical Medicine Research Institute', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer at pharmacy practice department, FUE, Egypt', 'investigatorFullName': 'Doaa abdelaziz', 'investigatorAffiliation': 'National Hepatology & Tropical Medicine Research Institute'}}}}