Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-06 @ 11:47 AM
Study NCT ID:
NCT05753267
Status:
RECRUITING
Last Update Posted:
2025-04-04
First Post:
2023-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fenofibrate in Ulcerative Colitis
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': 'D019804', 'term': 'Mesalamine'}, {'id': 'D011345', 'term': 'Fenofibrate'}], 'ancestors': [{'id': 'D062368', 'term': 'meta-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000636', 'term': 'Aminosalicylic Acids'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D058607', 'term': 'Fibric Acids'}, {'id': 'D058610', 'term': 'Isobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D001577', 'term': 'Benzophenones'}, {'id': 'D007659', 'term': 'Ketones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'double-blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-06-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-03', 'studyFirstSubmitDate': '2023-02-22', 'studyFirstSubmitQcDate': '2023-02-22', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint is the change in disease activity index and the improvement in health-related quality of life (HRQL)', 'timeFrame': '6 months', 'description': 'HRQL questionnaire will be assessed according to bowel symptoms, emotional symptoms, systemic symptoms, and social symptoms.'}], 'secondaryOutcomes': [{'measure': 'The secondary endpoint is estimated by changes in serum interleukin (IL-6) and nitric oxide (NO)', 'timeFrame': '6 months', 'description': 'The secondary endpoint is estimated by changes in serum interleukin (IL-6) and nitric oxide (NO)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Diseases']}, 'referencesModule': {'references': [{'pmid': '41330887', 'type': 'DERIVED', 'citation': 'Aldossary KM, Abdallah MS, Kamal N, Bahgat MM, Alrubia S, Alsegiani AS, Bahaa MM, Hassan AS, El-Khateeb E. Therapeutic Modulation of IL-6/STAT-3 and Nitric Oxide by Fenofibrate in Patients With Ulcerative Colitis: A Randomized Controlled Pilot Study. Pharmacotherapy. 2025 Dec 2. doi: 10.1002/phar.70088. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'Fibrates, which are specific pharmacological agonists of PPARα, have been widely used in the treatment of hypercholesterolemia and hypertriglyceridemia. Apart from their metabolic action, anti-inflammatory properties of fibrates have been described, including inhibition of NF-kappa B signaling and pro-inflammatory cytokine production. 4 Fenofibrate, an important peroxisome proliferator-activated receptor-a (PPAR- α) agonist, is widely used in clinical as a triglyceride (TG)-lowering agent.', 'detailedDescription': '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.\n\nPPARα has been proposed as a key lipid metabolism modulator and regulator of inflammation. There are three isotypes of PPAR (α, β and ȣ) which have distinct but overlapping functions.\n\nFibrates, which are specific pharmacological agonists of PPARα, have been widely used in the treatment for hypercholesterolemia and hypertriglyceridemia. Apart from their metabolic action, anti-inflammatory properties of fibrates have been described, including inhibition of NF-kappa B signaling and pro-inflammatory cytokine production. 4 Fenofibrate, an important peroxisome proliferator- activated receptor-a (PPAR- α) agonist, is widely used in clinical as a triglyceride (TG)-lowering agent'}, '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* Mild and moderate UC patients diagnosed and confirmed by an endoscope\n\nExclusion Criteria:\n\n* Breastfeeding\n* Significant liver and kidney function abnormalities\n* Colorectal cancer patients\n* Other inflammatory bowel diseases (CD).\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 Fenofibrate'}, 'identificationModule': {'nctId': 'NCT05753267', 'briefTitle': 'Fenofibrate in Ulcerative Colitis', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Clinical Study to Evaluate the Possible Efficacy of Fenofibrate in Patient With Ulcerative Colitis', 'orgStudyIdInfo': {'id': 'R.23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Mesalamine group will receive 1 g mesalamine three times daily for 6 months', 'interventionNames': ['Drug: Mesalamine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fenofibrate group', 'description': 'Fenofibrate group will receive 1 g mesalamine three times daily plus Fenofibrate (160 mg/day) for 6 months', 'interventionNames': ['Drug: Fenofibrate 160mg']}], 'interventions': [{'name': 'Mesalamine', 'type': 'DRUG', 'description': 'Mesalamine (also known as mesalamine or 5- amino salicylic acid, 5-ASA) has a well-established role in UC management. It is the first line therapy for mild to moderate UC and it is considered the cornerstone in the management of UC', 'armGroupLabels': ['Control Group']}, {'name': 'Fenofibrate 160mg', 'type': 'DRUG', 'description': 'Fibrates, which are specific pharmacological agonists of PPARα, have been widely used in the treatment of hypercholesterolemia and hypertriglyceridemia.', 'armGroupLabels': ['Fenofibrate group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Eman I Elberri, PhD', 'role': 'CONTACT', 'email': 'mbahaa@horus.edu.eg', 'phone': '0201003592593'}, {'name': 'Mostafa M Bahaa, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Tanta Unuversity', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Mostafa Bahaa, PhD', 'role': 'CONTACT', 'email': 'mbahaa@horus.edu.eg', 'phone': '0201025538337'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hend El-Said Abo Mansour, Faculty of Pharmacy, Menoufia University', 'class': 'UNKNOWN'}, {'name': 'Monir Hussein Bahgat, Faculty of Medicine, Mansura University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Teaching Assistant', 'investigatorFullName': 'Mostafa Bahaa', 'investigatorAffiliation': 'Tanta University'}}}}