Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-31 @ 3:08 AM
Study NCT ID:
NCT00079833
Status:
COMPLETED
Last Update Posted:
2010-11-19
First Post:
2004-03-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Esomeprazole In Patients With Gastric Acid Hypersecretory States Including Idiopathic Hypersecretion and Zollinger-Ellison Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015043', 'term': 'Zollinger-Ellison Syndrome'}], 'ancestors': [{'id': 'D009384', 'term': 'Paraneoplastic Endocrine Syndromes'}, {'id': 'D010257', 'term': 'Paraneoplastic Syndromes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D010437', 'term': 'Peptic Ulcer'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11'}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-18', 'studyFirstSubmitDate': '2004-03-16', 'studyFirstSubmitQcDate': '2004-03-16', 'lastUpdatePostDateStruct': {'date': '2010-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-03-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the gastric acid secretory rate at the final study visit.'}, {'measure': 'Control is defined as gastric acid secretory rate below 10 mEq/h or below 5 meq/h for patients with prior gastric acid reducing Surgery'}], 'secondaryOutcomes': [{'measure': 'The status (controlled or not controlled) of gastric acid secretory rate at the Month 6 study visit.'}, {'measure': 'Control is defined as gastric acid secretory rate below 10 mEq/h or below 5 meq/h for patients with prior gastric acid reducing surgery.'}, {'measure': 'The following safety variables will be assessed at Month 6 and Month 12: adverse events, clinical laboratory results (ie, chemistry, hematology, urinalysis), physical examinations, and EGDs.'}]}, 'conditionsModule': {'keywords': ['gastric acid hypersecretory conditions', 'Idiopathic Hypersecretion', 'Excessive Gastric Acid secretion'], 'conditions': ['Zollinger-Ellison Syndrome']}, 'descriptionModule': {'briefSummary': 'This research study will determine if esomeprazole, when administered twice daily at 40, 80, or 120 mg doses, can control excessive stomach acid secretion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females at least 18 years of age.\n* Diagnosis of Zollinger-Ellison Syndrome or idiopathic hypersecretion\n\nExclusion Criteria:\n\n* Pregnant or lactating females\n* History of drug addiction or alcohol abuse within 12 months prior to Screening.\n* History of intolerance to any proton pump inhibitors or any ingredient in their formulation.'}, 'identificationModule': {'nctId': 'NCT00079833', 'briefTitle': 'Esomeprazole In Patients With Gastric Acid Hypersecretory States Including Idiopathic Hypersecretion and Zollinger-Ellison Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase III, Multicenter, Open-Label Study To Evaluate the Control of Gastric Acid Secretion With Esomeprazole In Patients With Gastric Acid Hypersecretory States Including Idiopathic Hypersecretion and Zollinger-Ellison Syndrome For 12 Months', 'orgStudyIdInfo': {'id': 'D9612C00025'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Esomeprazole magnesium (Nexium)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'city': 'King of Prussia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.08927, 'lon': -75.39602}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Clichy', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'city': 'Paris', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Saint-Germain-en-Laye', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 48.89643, 'lon': 2.0904}}], 'overallOfficials': [{'name': 'Nexium Medical Science Director, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}