Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-02 @ 3:32 AM
Study NCT ID:
NCT00524251
Status:
COMPLETED
Last Update Posted:
2008-09-17
First Post:
2007-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Lifestyle-Adjustments Prior to Medical Treatment on the Effect of Medical Treatment in Reflux Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], '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'}]}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 990}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-16', 'studyFirstSubmitDate': '2007-08-29', 'studyFirstSubmitQcDate': '2007-08-31', 'lastUpdatePostDateStruct': {'date': '2008-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-03', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Patients with reflux complaints', 'GERD', 'quality of life', 'lifestyle adjustments'], 'conditions': ['GERD', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the improvement in the quality of life after an initial treatment with esomeprazole 40mg for reflux disease is the same in patients who have already made lifestyle-adjustments as in patients who have not implemented lifestyle-adjustments prior to the start of treatment (baseline)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with reflux complaints\n* 18 years of age\n\nExclusion Criteria:\n\n* Restrictions as mentioned in the registration text\n* H2RA or PPI use in the month prior to inclusion'}, 'identificationModule': {'nctId': 'NCT00524251', 'briefTitle': 'The Effect of Lifestyle-Adjustments Prior to Medical Treatment on the Effect of Medical Treatment in Reflux Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'orgStudyIdInfo': {'id': 'N11'}}, 'armsInterventionsModule': {'interventions': [{'name': 'esomeprazole', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': "'s-Gravenzande", 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.00167, 'lon': 4.16528}}, {'city': 'Almere Stad', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.37025, 'lon': 5.21413}}, {'city': 'Apeldoorn', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.21, 'lon': 5.96944}}, {'city': 'Baarn', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.21167, 'lon': 5.2875}}, {'city': 'Bennebroek', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.32083, 'lon': 4.59861}}, {'city': 'Blaardingen', 'country': 'Netherlands', 'facility': 'Research Site'}, {'city': 'Boekel', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 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'INDUSTRY'}}}}