Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-31 @ 12:53 PM
Study NCT ID:
NCT05567068
Status:
COMPLETED
Last Update Posted:
2025-11-18
First Post:
2022-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atorvastatin Efficacy and Safety in Patients With 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': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D019804', 'term': 'Mesalamine'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'double-blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-15', 'studyFirstSubmitDate': '2022-10-01', 'studyFirstSubmitQcDate': '2022-10-04', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in health related quality of life', 'timeFrame': '6 months', 'description': 'HRQL questionnaire will be assessed according to bowel symptoms, emotional symptoms, systemic symptoms, and social symptoms'}], 'secondaryOutcomes': [{'measure': 'changes in serum and fecal inflammatory biomarkers', 'timeFrame': '6 months', 'description': 'The secondary endpoint is estimated by changes in serum IL-18, and fecal calprotectin.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Diseases']}, 'referencesModule': {'references': [{'pmid': '41235106', 'type': 'DERIVED', 'citation': 'Khrieba MO, Abdulelah FM, Alsaleh NA, AlRasheed HA, Ahmed TI, El-Sayed Mansy A, Hamouda MA, Habba E, Elshorbagi N, Abd Elhameed AG, Hamza E, Salahuddin MM, Mourad SA, Kamal M. Atorvastatin as an immunomodulatory adjunct in ulcerative colitis, beyond lipid lowering to inflammation control: a randomized controlled pilot study. Front Pharmacol. 2025 Oct 29;16:1690513. doi: 10.3389/fphar.2025.1690513. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'Statins exert numerous pleiotropic effects including anti-inflammatory, antioxidant properties, endothelial function improvement, and immunomodulation independent of their basic lipid-lowering properties.'}, '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* Breastfeeding\n* Significant liver and kidney function abnormalities\n* Colorectal cancer patients\n* Patients with severe UC\n* Patients taking rectal or systemic steroids\n* Patients taking immunosuppressives or biological therapies'}, 'identificationModule': {'nctId': 'NCT05567068', 'briefTitle': 'Atorvastatin Efficacy and Safety in Patients With Ulcerative Colitis', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Repurposing Atorvastatin in Patients With Ulcerative Colitis Treated With Mesalamine by Modulation of mTOR/NLRP3 Pathway.', 'orgStudyIdInfo': {'id': '3433'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control Group', 'description': 'This group will take mesalamine 1 g three times daily', 'interventionNames': ['Drug: Mesalamine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Atorvastatin group', 'description': 'This group will take mesalamine 1 g three times daily plus atorvastatin 80 mg once daily.', 'interventionNames': ['Drug: Atorvastatin 80mg', 'Drug: Mesalamine']}], 'interventions': [{'name': 'Atorvastatin 80mg', 'type': 'DRUG', 'description': 'Atrovastatin is one of the most effective drugs used to reduce intracellular cholesterol synthesis. it exerts numerous pleiotropic effects including anti-inflammatory, antioxidant properties, endothelial function improvement and immunomodulation independent of its basic lipid-lowering properties', 'armGroupLabels': ['Atorvastatin group']}, {'name': 'Mesalamine', 'type': 'DRUG', 'description': 'Mesalamine', 'armGroupLabels': ['Atorvastatin group', 'Control 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'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Teaching Assistant', 'investigatorFullName': 'Mostafa Bahaa', 'investigatorAffiliation': 'Tanta University'}}}}