Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-25 @ 3:14 PM
Study NCT ID:
NCT00318968
Status:
COMPLETED
Last Update Posted:
2009-01-26
First Post:
2006-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nexium RESPONSE Trial
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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-23', 'studyFirstSubmitDate': '2006-04-26', 'studyFirstSubmitQcDate': '2006-04-26', 'lastUpdatePostDateStruct': {'date': '2009-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The primary efficacy variable is the patient's key complaint. A patient whose key complaint has been absent for the last 24 hour of the treatment period (2 weeks +/- 2 days) is defined as a PPI responder."}], 'secondaryOutcomes': [{'measure': 'To evaluate the response rate (absence of the key complaint for the last 3 days of the treatment period (2 weeks +/- 2 days)).'}]}, 'conditionsModule': {'keywords': ['Acid Reflux', 'Nexium', 'Esomeprazole'], 'conditions': ['GERD']}, 'referencesModule': {'references': [{'pmid': '22759841', 'type': 'DERIVED', 'citation': 'Bytzer P, Langkilde LK, Christensen E, Meineche-Schmidt V. Work productivity improvement after acid suppression in patients with uninvestigated dyspepsia. Dan Med J. 2012 Jul;59(7):A4461.'}, {'pmid': '21083590', 'type': 'DERIVED', 'citation': 'Meineche-Schmidt V, Christensen E, Bytzer P. Randomised clinical trial: identification of responders to short-term treatment with esomeprazole for dyspepsia in primary care - a randomised, placebo-controlled study. Aliment Pharmacol Ther. 2011 Jan;33(1):41-9. doi: 10.1111/j.1365-2036.2010.04501.x. Epub 2010 Oct 29.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of the study is to develop, and test, an algorithm for identification of responders to empirical esomeprazole treatment in general practices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients attending general practice due to symptoms suggestive of acid related disease and, according to normal routine, the GP would prescribe an acid-inhibiting agent\n\nExclusion Criteria:\n\n* Alarm symptoms\n* Pregnancy\n* Contraindications to Nexium'}, 'identificationModule': {'nctId': 'NCT00318968', 'briefTitle': 'Nexium RESPONSE Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Development of an Algorithm for Identification of Responders to Short Term Treatment With Esomeprazole (Nexium) in Primary Care', 'orgStudyIdInfo': {'id': 'D9612L00076'}, 'secondaryIdInfos': [{'id': 'RESPONSE'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Esomeprazole', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aabenraa', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.04434, 'lon': 9.41741}}, {'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'city': 'Albek', 'country': 'Denmark', 'facility': 'Research Site'}, {'city': 'Ans', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 56.30712, 'lon': 9.59276}}, {'city': 'Arhus C', 'country': 'Denmark', 'facility': 'Research Site'}, {'city': 'Bagsværd', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.76095, 'lon': 12.45317}}, {'city': 'Birkerød', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.84759, 'lon': 12.42791}}, {'city': 'Brønshøj', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.70571, 'lon': 12.49637}}, {'city': 'Farum', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.80858, 'lon': 12.36066}}, {'city': 'Fredericia', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.56568, 'lon': 9.75257}}, {'city': 'Frederikshavn', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 57.44073, 'lon': 10.53661}}, {'city': 'Frederikssund', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.83956, 'lon': 12.06896}}, {'city': 'Gråsten', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 54.91918, 'lon': 9.59523}}, {'city': 'Haslev', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.32346, 'lon': 11.96389}}, {'city': 'Herning', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 56.13615, 'lon': 8.97662}}, {'city': 'Hinnerup', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 56.7347, 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{'city': 'Tåstrup', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 56.29074, 'lon': 10.57669}}, {'city': 'Tønder', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 54.93306, 'lon': 8.86674}}, {'city': 'Ullerslev', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.36172, 'lon': 10.6519}}, {'city': 'Viborg', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 56.45319, 'lon': 9.40201}}, {'city': 'Viby J', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 56.12259, 'lon': 10.15145}}], 'overallOfficials': [{'name': 'Villy Meineche Schmidt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charlottenlund Research Site'}, {'name': 'Stig Waldorff, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}