Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-31 @ 10:20 PM
Study NCT ID:
NCT04217733
Status:
RECRUITING
Last Update Posted:
2020-01-03
First Post:
2019-12-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ethosuximide and Pentoxifylline in the Treatment of Abdominal Pain Related to Irritable Bowel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C005096', 'term': 'mebeverine'}, {'id': 'D005013', 'term': 'Ethosuximide'}], 'ancestors': [{'id': 'D013388', 'term': 'Succinimides'}, {'id': 'D007094', 'term': 'Imides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2030-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-02', 'studyFirstSubmitDate': '2019-12-29', 'studyFirstSubmitQcDate': '2020-01-02', 'lastUpdatePostDateStruct': {'date': '2020-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with improved Visual analog scales (VAS) for assessment of pain in IBS', 'timeFrame': '6 months', 'description': 'the number of patients with improved Visual analog scales (VAS) for assessment of pain in IBS'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['IBS - Irritable Bowel Syndrome']}, 'referencesModule': {'references': [{'pmid': '35221706', 'type': 'DERIVED', 'citation': 'El-Haggar SM, Hegazy SK, Abd-Elsalam SM, Elkaeed EB, Al-Karmalawy AA, Bahaa MM. A Potential Role of Ethosuximide and Pentoxifylline in Relieving Abdominal Pain in Irritable Bowel Syndrome Patients Treated with Mebeverine: A Randomized, Double-Blind, Placebo-Controlled Trial. J Inflamm Res. 2022 Feb 19;15:1159-1172. doi: 10.2147/JIR.S346608. eCollection 2022.', 'retractions': [{'pmid': '35444453', 'source': 'J Inflamm Res. 2022 Apr 14;15:2381-2382'}]}, {'pmid': '34726293', 'type': 'DERIVED', 'citation': 'El-Haggar SM, Hegazy SK, M Abd-Elsalam S, Bahaa MM. Open-label pilot study of ethosuximide as adjunctive therapy for relieving abdominal pain related to Irritable Bowel Syndrome. J Clin Pharm Ther. 2022 Mar;47(3):306-312. doi: 10.1111/jcpt.13556. Epub 2021 Nov 2.'}]}, 'descriptionModule': {'briefSummary': 'Ethosuximide and pentoxifylline in the treatment of abdominal pain related to irritable bowel syndrome', 'detailedDescription': 'Ethosuximide and pentoxifylline in the treatment of abdominal pain related to irritable bowel syndrome: Does this add to current treatment?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Age ≥ 18 years,\n\n * Man and Women, Negative pregnancy test and effective contraception,\n * IBS defined by the Rome criteria IV\n * During the previous seven days the inclusion visit, average numeric rating scale (NRS) pain ≥ 4.\n * IBS Treatment stable for 1 month\n\nExclusion Criteria:\n\n* • Breastfeeding\n\n * Diabetic patients\n * Significant liver function abnormalities (transaminases\\> 3N, cholestasis) and moderate renal disease (MDRD \\<60 ml / min)\n * Addiction to alcohol and / or drugs,\n * Antiepileptic drugs taken (epilepsy or chronic pain)\n * Chronic pain of greater intensity than that related to IBS,\n * Known Allergyto succinimides (ethosuximide, methsuximide, phensuximide) and pentoxifylline.\n * History or current severe depression (hospitalization, long-term antidepressant treatment)\n * Psychotic disorders,'}, 'identificationModule': {'nctId': 'NCT04217733', 'briefTitle': 'Ethosuximide and Pentoxifylline in the Treatment of Abdominal Pain Related to Irritable Bowel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'A Comparative Study to Assess Safety and Effectiveness of Ethosuximide and Pentoxifylline in the Treatment of Abdominal Pain Related to Irritable Bowel Syndrome', 'orgStudyIdInfo': {'id': 'Sherief Protocol'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mebeverine', 'description': 'Mebeverine 3 times daily for 3 months', 'interventionNames': ['Drug: Mebeverine']}, {'type': 'EXPERIMENTAL', 'label': 'Ethosuximide', 'description': 'Ethosuxemide 3 times daily for 3 months', 'interventionNames': ['Drug: ethosuximide']}, {'type': 'EXPERIMENTAL', 'label': 'Pentoxyifylline', 'description': 'pentoxyifylline 2 times daily for 3 months', 'interventionNames': ['Drug: pentoxyifylline']}], 'interventions': [{'name': 'pentoxyifylline', 'type': 'DRUG', 'description': 'Pentoxyifylline two times daily for 3 months', 'armGroupLabels': ['Pentoxyifylline']}, {'name': 'Mebeverine', 'type': 'DRUG', 'description': 'Mebeverine 3 times for 3 months', 'armGroupLabels': ['Mebeverine']}, {'name': 'ethosuximide', 'type': 'DRUG', 'description': 'ethosuximide 3 times for 3 months', 'armGroupLabels': ['Ethosuximide']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Sherief Abd-Elsalam, Ass. Prof.', 'role': 'CONTACT', 'email': 'sheriefabdelsalam@yahoo.com', 'phone': '00201009221243'}], 'facility': 'Sherief Abd-Elsalam', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Sherief Abd-Elsalam, ass. prof.', 'role': 'CONTACT', 'email': 'sheriefabdelsalam@yahoo.com', 'phone': '00201147773440'}], 'overallOfficials': [{'name': 'Mostafa Mahmoud Bahaa El dien, Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Pharmacy department'}, {'name': 'Sahar El-Haggar, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical pharmacy Department- Tanta University'}, {'name': 'Sahar Hegazy, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical pharmacy Department- Tanta University'}, {'name': 'Sherief Abd-Elsalam, Ass. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tropical Medicine Department- Tanta University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ass. Prof. Tropical Medicine', 'investigatorFullName': 'Sherief Abd-Elsalam', 'investigatorAffiliation': 'Tanta University'}}}}