Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2025-12-27 @ 4:15 AM
Study NCT ID:
NCT00410592
Status:
COMPLETED
Last Update Posted:
2009-03-11
First Post:
2006-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of 24-Hour Intragastric pH Using Esomeprazole, Lansoprazole, and Pantoprazole in Hispanic Patients With GERD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D006356', 'term': 'Heartburn'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064098', 'term': 'Esomeprazole'}, {'id': 'D000077402', 'term': 'Pantoprazole'}, {'id': 'D064747', 'term': 'Lansoprazole'}], '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-10', 'studyFirstSubmitDate': '2006-12-12', 'studyFirstSubmitQcDate': '2006-12-12', 'lastUpdatePostDateStruct': {'date': '2009-03-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the pharmacodynamic efficacy in controlling intragastric pH following administration of esomeprazole 40 mg, lansoprazole 30 mg, and pantoprazole 40 mg taken orally, once daily in Hispanic patients with symptomatic GERD.'}], 'secondaryOutcomes': [{'measure': 'Compare nocturnal intragastric pH in Hispanic patients with GERD'}, {'measure': 'Compare integrated acidity (IGA) using 24-hour monitoring period among Hispanic patients with GERD'}, {'measure': 'Assess the short-term safety and tolerability of PPIs being studied in Hispanic patients'}]}, 'conditionsModule': {'keywords': ['GERD', 'acid reflux', 'heartburn', 'PPI', 'Hispanic'], 'conditions': ['Gastroesophageal Reflux Disease']}, 'referencesModule': {'references': [{'pmid': '20456300', 'type': 'DERIVED', 'citation': 'Morgan D, Pandolfino J, Katz PO, Goldstein JL, Barker PN, Illueca M. Clinical trial: gastric acid suppression in Hispanic adults with symptomatic gastro-oesophageal reflux disease - comparator study of esomeprazole, lansoprazole and pantoprazole. Aliment Pharmacol Ther. 2010 Jul;32(2):200-8. doi: 10.1111/j.1365-2036.2010.04335.x. Epub 2010 Apr 23.'}]}, 'descriptionModule': {'briefSummary': 'This study will be conducted in order to determine safety and efficacy esomeprazole, lansoprazole and pantoprazole control stomach acid by measuring the stomach acid in men and women of Hispanic origin who have GERD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Males and females ages 18-69 who are of Hispanic origin\n* Symptoms of GERD, defined as heartburn at least 2 times a week on average over the last 3 months\n\nExclusion Criteria:\n\n* Female patients who are pregnant or breastfeeding\n* Known intolerance or lack of response to Proton Pump Inhibitors (PPIs) such as Nexium, Prevacid, or Protonix\n* Current or relevant history of non-healed ulcers, stomach surgery, or esophageal surgery'}, 'identificationModule': {'nctId': 'NCT00410592', 'briefTitle': 'Evaluation of 24-Hour Intragastric pH Using Esomeprazole, Lansoprazole, and Pantoprazole in Hispanic Patients With GERD', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomized, Open-Label, Comparative 3-Way Crossover Study of 24-Hour Intragastric pH Profile of Once Daily Oral Administration of Esomeprazole 40 mg, Lansoprazole 30 mg, and Pantoprazole 40 mg at Steady State in Hispanic Patients With Symptomatic GERD', 'orgStudyIdInfo': {'id': 'D9612L00106'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Esomeprazole 40mg', 'type': 'DRUG'}, {'name': 'Pantoprazole 40mg', 'type': 'DRUG'}, {'name': 'Lansoprazole 30mg', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research SIte', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Research Site', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Marta Illueca, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}, {'name': 'Kathryn Collison', 'role': 'STUDY_CHAIR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}