Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-25 @ 1:52 PM
Study NCT ID:
NCT01432392
Status:
COMPLETED
Last Update Posted:
2012-05-10
First Post:
2011-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Symptom Control and Impact on Daily Life in Patients With Gastroesophageal Reflux Disease
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-09', 'studyFirstSubmitDate': '2011-09-09', 'studyFirstSubmitQcDate': '2011-09-12', 'lastUpdatePostDateStruct': {'date': '2012-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change in intensity and frequency for each of typical GERD symptoms from baseline to week 4-6', 'timeFrame': 'Day 0 to week 4-6'}, {'measure': 'Changes in GERD questionnaire(GERD-Q) scores from baseline to week 4-6', 'timeFrame': 'Day 0 to week 4-6'}], 'secondaryOutcomes': [{'measure': 'To evaluate the correlation between GERD-Q scores and symptom scores', 'timeFrame': 'two times'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['gastroesophageal reflux disease', 'GERD questionnaire', 'primary care setting'], 'conditions': ['Gastroesophageal Reflux Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the impact of gastroesophageal reflux disease (GERD) treatment in primary care setting on symptom control and daily life in symptomatic GERD patients, using both GERD questionnaire and clinical symptoms assessment', 'detailedDescription': 'A prospective, observational study to describe symptom control and impact on daily life in patients with gastroesophageal reflux disease (GERD)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'primary care setting', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients known or newly diagnosed with GERD\n* Patients with typical GERD symptoms as heartburn and regurgitation for ≥2 days in the previous week\n* Patients, currently not treated with a proton pump inhibitor\n\nExclusion Criteria:\n\n* Patients who have been receiving treatment with non-steroidal antiinflammatory drugs within two weeks prior the inclusion in the study\n* Patients with medical history of surgery of the esophagus, stomach or duodenum\n* Pregnant or nursing females'}, 'identificationModule': {'nctId': 'NCT01432392', 'briefTitle': 'Symptom Control and Impact on Daily Life in Patients With Gastroesophageal Reflux Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Prospective, Observational Study to Describe Symptom Control and Impact on Daily Life in Patients With Gastroesophageal Reflux Disease (GERD)', 'orgStudyIdInfo': {'id': 'NIS-GBG-XXX-2011/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sofia', 'country': 'Bulgaria', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Varna', 'country': 'Bulgaria', 'geoPoint': {'lat': 43.21912, 'lon': 27.91024}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}