Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-28 @ 9:14 PM
Study NCT ID:
NCT00343161
Status:
COMPLETED
Last Update Posted:
2011-01-24
First Post:
2006-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Symptom Adapted Therapy in GERD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Portugal']}, '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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 441}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-21', 'studyFirstSubmitDate': '2006-06-20', 'studyFirstSubmitQcDate': '2006-06-21', 'lastUpdatePostDateStruct': {'date': '2011-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the efficacy of three different long-term treatment strategies in primary care setting'}, {'measure': 'To compare treatments separately within different levels of symptom load according to clinical judgement at baseline'}, {'measure': "Number of 'treatment failures' used as primary outcome variable."}], 'secondaryOutcomes': [{'measure': 'To evaluate whether the Reflux Disease Questionnaire (RDQ)used in primary care setting adds value to clinical judgement in assessing baseline symptom load'}, {'measure': 'Evaluate whether the RDQ facilitates the decision on appropriate acute and maintenance treatment strategy'}, {'measure': 'To assess the additional impact of a concomitant low dose acetylsalicylic acid (ASA) therapy during acute and maintenance phase with regard to efficacy'}, {'measure': 'To evaluate whether there is a difference between treatment strategies with regard to patient satisfaction during maintenance phase using the GERD Impact Scale'}]}, 'conditionsModule': {'keywords': ['Nexium'], 'conditions': ['Gastroesophageal Reflux Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether a maintenance treatment over 12 weeks with esomeprazole 20 mg daily will sufficiently give control over GERD symptoms and how it compares either with an on-demand therapy with esomeprazole 20 mg or an as needed therapy (wait and see regimen) with rescue medication only (antacid), following a 4-weeks acute treatment phase with either esomeprazole 20 mg or esomeprazole 40 mg.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Patients who seek medical advice in primary care for symptoms thought to be GERD-related\n\nExclusion Criteria:\n\n* Clinical GERD diagnosis/treatment within last 3 month\n* History of severe esophagitis (i.e. LA grade C or D)\n* Previous anti-reflux surgery\n* History of drug abuse\n* Female patients who are pregnant or lactating or at risk of pregnancy'}, 'identificationModule': {'nctId': 'NCT00343161', 'acronym': 'SYMPATHY', 'briefTitle': 'Symptom Adapted Therapy in GERD Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomized, Open, Parallel-group, Multi-national, Multi-centre, Phase IV Study to Evaluate the Efficacy of Three Different Patient Management Strategies With and Without Esomeprazole 20 mg During a 3 Months Maintenance Phase Following an Initial 4-weeks Acute Treatment Phase in Subjects With Symptoms Thought to be GERD Related', 'orgStudyIdInfo': {'id': 'D9612L00109'}, 'secondaryIdInfos': [{'id': 'SYMPATHY'}, {'id': 'EudraCT-No. 2006-001316-76'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'esomeprazole', 'type': 'DRUG'}, {'name': 'Gelusil-Lac (Aluminum hydroxide gel,magnesium trisilicate)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aiterhofen', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 48.84659, 'lon': 12.62012}}, {'city': 'Ansbach', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.30481, 'lon': 10.5931}}, {'city': 'Apolda', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.02624, 'lon': 11.51638}}, {'city': 'Bad Bramstedt', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 53.91827, 'lon': 9.88243}}, {'city': 'Bad Frankenhausen', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.35609, 'lon': 11.09977}}, {'city': 'Bad Salzuflen', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.0862, 'lon': 8.74434}}, {'city': 'Bad Schwartau', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 53.91887, 'lon': 10.69691}}, {'city': 'Baden-Baden', 'country': 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Jung-Stilling-Krankenhaus, Siegen, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}