Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT05575505
Status:
RECRUITING
Last Update Posted:
2025-03-04
First Post:
2022-10-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phosphodiesterase Inhibitors, Pentoxifylline, as Adjunctive Therapy 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': 'D010431', 'term': 'Pentoxifylline'}], 'ancestors': [{'id': 'D013805', 'term': 'Theobromine'}, {'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, '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': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-01', 'studyFirstSubmitDate': '2022-10-08', 'studyFirstSubmitQcDate': '2022-10-08', 'lastUpdatePostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in Mayo Score Index.', 'timeFrame': '6 months', 'description': 'The Mayo Score for ulcerative colitis disease activity assesses disease severity and can be used to monitor patients during therapy.\n\nThis scale uses four parameters to calculate the patient scores from 0-12. The parameters assessed are rectal bleeding, stool frequency, endoscopic findings, and physician assessment. Higher scores mean poor progression. Lower scores mean good progression'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Diseases']}, '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. Also, it is associated with high risk of colon cancer, so there is a continuous need for introducing new therapies that decrease progression, and hence better outcomes'}, '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\n* Addiction to alcohol and / or drugs'}, 'identificationModule': {'nctId': 'NCT05575505', 'briefTitle': 'Phosphodiesterase Inhibitors, Pentoxifylline, as Adjunctive Therapy in Patients With Ulcerative Colitis.', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Phosphodiesterase Inhibitors, Pentoxifylline, as Adjunctive Therapy in Patients With Ulcerative Colitis.', 'orgStudyIdInfo': {'id': '11/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Mesalamine group, who will receive 1 g mesalamine three times daily for 6 months.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pentoxifylline group', 'description': 'The pentoxifylline group will receive 1 g mesalamine three times daily plus pentoxifylline 400 mg two times daily for 6 months.', 'interventionNames': ['Drug: Pentoxifylline 400 MG']}], 'interventions': [{'name': 'Pentoxifylline 400 MG', 'type': 'DRUG', 'description': 'Pentoxifylline (PTX) is a methyl-xanthine derivative that possesses antioxidant and anti-inflammatory characteristics', 'armGroupLabels': ['Pentoxifylline group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35511', 'city': 'Al Mansurah', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mostafa M Bahaa, PhD', 'role': 'CONTACT', 'email': 'mbahaa@horus.edu.eg', 'phone': '0201025538337'}], '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'}}}}