Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-01-02 @ 9:59 AM
Study NCT ID:
NCT00637559
Status:
COMPLETED
Last Update Posted:
2011-01-25
First Post:
2008-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Barrett's Esophagus - 315 - 3 Way Cross-Over
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001471', 'term': 'Barrett Esophagus'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System 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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2003-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-24', 'studyFirstSubmitDate': '2008-03-11', 'studyFirstSubmitQcDate': '2008-03-11', 'lastUpdatePostDateStruct': {'date': '2011-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the total percent time during the 24-hour monitoring period that gastric pH is above 4.0 at steady state in patients when taking: esomeprazole 40mg twice daily, esomeprazole 40mg three times daily, esomeprazole 20 mg three times daily.', 'timeFrame': 'pH measured on Day 5'}], 'secondaryOutcomes': [{'measure': 'Compare total percent time distal esophageal pH is above 4.0 at steady state for each treatment period.', 'timeFrame': 'pH measured'}]}, 'conditionsModule': {'keywords': ['Nexium', "Barrett's esophagus"], 'conditions': ["Barrett's Esophagus"]}, 'descriptionModule': {'briefSummary': "This study looks the intragastric and intraesophageal pH in patients with documented Barrett's esophagus whilst taking esomeprazole 40mg twice daily, esomeprazole 40mg three times daily, esomeprazole 20 mg three times daily."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Must have a previously established, biopsy-proven diagnosis of Barrett's esophagus with segment length greater than 3cm, with no dysplasia or adenocarcinoma within the previous 12 months\n\nExclusion Criteria:\n\n* A history of esophageal, gastric, or duodenal surgery, including anti-reflux surgery or endoscopic anti-reflux procedures, except for simple closure of a gastric or duodenal ulcer.\n* History of various gastrointestinal diseases - please see investigator for full list.\n* Evidence of any malignant disease in the last 5 years, except minor superficial skin disease.\n* Unstable diabetes mellitus. Stable on a controlled diet, oral agents or insulin are acceptable."}, 'identificationModule': {'nctId': 'NCT00637559', 'briefTitle': "Barrett's Esophagus - 315 - 3 Way Cross-Over", 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': "A Multicenter, Double-blind, Three-way Crossover Intraesophageal and Intragastric pH Study of Three Esomeprazole Treatment Regimens in Documented Barrett's Esophagus Patients", 'orgStudyIdInfo': {'id': '315'}, 'secondaryIdInfos': [{'id': 'D9612L00056'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '40mg twice daily', 'interventionNames': ['Drug: Esomeprazole Magnesium']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': '40mg three times daily', 'interventionNames': ['Drug: Esomeprazole Magnesium']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': '20mg three times daily', 'interventionNames': ['Drug: Esomeprazole Magnesium']}], 'interventions': [{'name': 'Esomeprazole Magnesium', 'type': 'DRUG', 'otherNames': ['Nexium'], 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Paula Fernstrom', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nexium Global Product Director, AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Tore Lind, MD - Nexium Medical Science Director', 'oldOrganization': 'Astra Zeneca'}}}}