Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-30 @ 3:51 PM
Study NCT ID:
NCT05287633
Status:
COMPLETED
Last Update Posted:
2025-02-25
First Post:
2020-09-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proton Pump Inhibitors Effects on Dyspepsia During Ramadan Fasting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004415', 'term': 'Dyspepsia'}, {'id': 'D005215', 'term': 'Fasting'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064098', 'term': 'Esomeprazole'}], 'ancestors': [{'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'the objective is to evaluate the interest of proton pump inhibitors in subjects with or without GI symptoms who intend to observe fasting in Ramadan. We will compare the effectiveness of proton pump inhibitors to prevent or reduce the signs of dyspepsia during at least Ramadan as compared to placebo.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-23', 'studyFirstSubmitDate': '2020-09-10', 'studyFirstSubmitQcDate': '2022-03-16', 'lastUpdatePostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall symptom relief during the 4 weeks of treatment', 'timeFrame': '30 days after inclusion', 'description': 'Relief of dyspepsia symptoms during the treatment period according to the decrease of SF-LDQ score'}], 'secondaryOutcomes': [{'measure': 'number of days without dyspepsia', 'timeFrame': '30 days after inclusion', 'description': 'the number of days with SF-LDQ score \\<1'}, {'measure': 'quality of life assessment', 'timeFrame': '30 days after inclusion', 'description': 'quality of life assessment ccording to the SF-36 score'}, {'measure': 'Patients satisfaction of the treatment', 'timeFrame': '30 days after inclusion', 'description': 'Patients satisfaction according to Likert score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fasting', 'Proton Pump Inhibitors', 'dyspepsia'], 'conditions': ['Dyspepsia']}, 'referencesModule': {'references': [{'pmid': '41120363', 'type': 'DERIVED', 'citation': 'Hadrich S, Lamti F, Trabelsi I, Dhaoui R, Ben Abdewahed M, Sekma A, Neffati F, Boukadida L, Yaakoubi H, Jaballah R, Bakir A, Youssef R, Zorgati A, Bel Haj Ali K, Beltaief K, Dridi Z, Ben Hamda K, Jomaa W, Chamtouri I, Bendaya Y, Bouchoucha M, Ben Hafaeidh S, Razgallah R, Bouida W, Grissa MH, Sriha A, Khedher S, Khochtali I, Sakly N, Ben Soltane H, Hassine M, Boubaker H, Boukef R, Msolli MA, Nouira S. Randomized trial of the effect of esomeprazole on functional dyspepsia during Ramadan fasting. Sci Rep. 2025 Oct 21;15(1):36535. doi: 10.1038/s41598-025-17532-x.'}]}, 'descriptionModule': {'briefSummary': 'evaluate the interest of proton pump inhibitors in subjects with or with GI symptoms who intend to observe fasting in Ramadan. The investigators will compare the effectiveness of proton pump inhibitors to prevent or reduce the signs of dyspepsia during Ramadan compared to placebo.', 'detailedDescription': 'evaluate the interest of proton pump inhibitors in subjects with or with GI symptoms who intend to observe fasting in Ramadan. Investigators will compare the effectiveness of proton pump inhibitors to prevent or reduce the signs of dyspepsia during at least Ramadan compared to placebo.\n\nThe study will be conducted at least from April 2019 to at least June 2030.The study is prospective, two parallel groups, randomized controlled and double blind.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n* Diagnosed GastroDuodenal Ulcer'}, 'identificationModule': {'nctId': 'NCT05287633', 'briefTitle': 'Proton Pump Inhibitors Effects on Dyspepsia During Ramadan Fasting', 'organization': {'class': 'OTHER', 'fullName': 'University of Monastir'}, 'officialTitle': 'Proton Pump Inhibitors Effects on Dyspepsia During Ramadan Fasting', 'orgStudyIdInfo': {'id': 'PPI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A : Proton Pump Inhibitors', 'description': 'Patients are given proton pump inhibitors tablets once a day', 'interventionNames': ['Drug: Esomeprazole']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B: Placebo', 'description': 'Patients are given a placebo instead of proton pump inhibitors active drug', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Esomeprazole', 'type': 'DRUG', 'otherNames': ['Nexium'], 'description': 'Patients are given a box of capsules of which they take 1capsule/day during the month of ramadan', 'armGroupLabels': ['A : Proton Pump Inhibitors']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Patients are given a box of capsules of which they take 1capsule/day during the month of ramadan', 'armGroupLabels': ['B: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Monastir', 'country': 'Tunisia', 'facility': 'Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia', 'geoPoint': {'lat': 35.77799, 'lon': 10.82617}}], 'overallOfficials': [{'name': 'Semir Nouira, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Monastir'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Monastir', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Pr. Semir Nouira', 'investigatorAffiliation': 'University of Monastir'}}}}