Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-29 @ 5:13 PM
Study NCT ID:
NCT01608750
Status:
UNKNOWN
Last Update Posted:
2012-05-31
First Post:
2012-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Pantoprazole Treatment in Patients With Functional Dyspepsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077402', 'term': 'Pantoprazole'}, {'id': 'D005492', 'term': 'Folic Acid'}], 'ancestors': [{'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'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-05-30', 'studyFirstSubmitDate': '2012-05-28', 'studyFirstSubmitQcDate': '2012-05-30', 'lastUpdatePostDateStruct': {'date': '2012-05-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness of pantoprazole treatment in patients with functional dyspepsia measured by symptoms scale.', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Nonulcer Dyspepsia']}, 'descriptionModule': {'briefSummary': 'The aim of our study is to evaluate the effectiveness of proton pump inhibitor (PPI) treatment in patients with functional dyspepsia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 18-45 years with symptoms of dyspepsia,\n* no evidence of organic disease.\n\nExclusion Criteria:\n\n* Patients with alarm symptoms,\n* Severe concomitant illness,\n* Pregnancy or lactation,\n* Alcohol or drug abuse,\n* Use of aspirin or other non-steroidal anti-inflammatory drugs antibiotics, H2 receptor blockers, bismuth, or proton pump inhibitors in the preceding two weeks'}, 'identificationModule': {'nctId': 'NCT01608750', 'briefTitle': 'The Efficacy of Pantoprazole Treatment in Patients With Functional Dyspepsia', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': 'The Efficacy of Pantoprazole Treatment in Patients With Functional Dyspepsia: Randomised, Double-blind, Placebo-controlled Trial.', 'orgStudyIdInfo': {'id': 'B.30.2.BAV.0.05.05/331'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pantoprazole', 'interventionNames': ['Drug: Pantoprazol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'folic acid', 'interventionNames': ['Drug: Folic Acid']}], 'interventions': [{'name': 'Pantoprazol', 'type': 'DRUG', 'description': '40mg/day, oral, 28 days', 'armGroupLabels': ['pantoprazole']}, {'name': 'Folic Acid', 'type': 'DRUG', 'description': '5 mg/day, oral, 28 days', 'armGroupLabels': ['folic acid']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Birol Baysal', 'role': 'CONTACT', 'email': 'babbaysal@gmail.com', 'phone': '+905057758585'}, {'name': 'Birol Baysal', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bezmialem medical faculty', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezmialem Vakif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Gastroenterologist', 'investigatorFullName': 'Birol Baysal', 'investigatorAffiliation': 'Bezmialem Vakif University'}}}}