Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT01103804
Status:
COMPLETED
Last Update Posted:
2011-01-11
First Post:
2010-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Non-interventional Study to Evaluate the Change in Symptoms Scores and Treatment Response After 4 Weeks of Proton-Pump Inhibitors (PPI) Treatment
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': 952}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-10', 'studyFirstSubmitDate': '2010-04-13', 'studyFirstSubmitQcDate': '2010-04-13', 'lastUpdatePostDateStruct': {'date': '2011-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'describe the change in GerdQ sum scores, after a 4-week period of systematic treatment with PPIs(GerdQ)', 'timeFrame': '4 weeks(at V1 and V2)'}], 'secondaryOutcomes': [{'measure': 'measure the response at the current treatment after a 4-week period of systematic treatment with PPIs(GerdQ)', 'timeFrame': '4 weeks(at V1 and V2)'}, {'measure': 'identify the percentage of patients which require alterations of their treatment after a 4-week period of systematic treatment with PPIs(GerdQ)', 'timeFrame': '4 weeks(at V1 and V2)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GerdQ questionnaire'], 'conditions': ['Gastroesophageal Reflux']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to describe the change in GerdQ sum scores, after a 4-week period of systematic treatment with PPIs(using GerdQ questionnaire). The secondary objectives are: to measure the response at the current treatment after a 4-week period of systematic treatment and to identify the percentage of patients which require alterations of their treatment (GerdQ questionnaire)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population are patients known/newly diagnosed with GERD or with symptoms suggesting GERD( hearburn, regurgitations) who presented to their family physician(primary care clinic)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of informed consent\n* Patients known or newly diagnosed with GERD or patients with typical symptoms of GERD- heartburn, regurgitation (in the last case, GerdQ sum score should be ≥8, in the absence of PPI treatment)\n\nExclusion Criteria:\n\n* Any symptoms at visit 1 suggesting a need for further investigation, judged by the Investigator (alarm symptoms).The alarm symptoms suggesting complicated disease are: dysphagia, odynophagia, bleeding, weight loss without intention or anemia.\n* Previous participation in the present study'}, 'identificationModule': {'nctId': 'NCT01103804', 'briefTitle': 'Non-interventional Study to Evaluate the Change in Symptoms Scores and Treatment Response After 4 Weeks of Proton-Pump Inhibitors (PPI) Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Prospective, Non-interventional Study to Evaluate the Change in Symptoms Scores and Treatment Response After 4 Weeks of Systematic Treatment With PPIs in GERD Patients in Primary Care Setting in Romania, Using the Validated GerdQ Questionnaire.', 'orgStudyIdInfo': {'id': 'NIS-GRO-DUM-2009/1'}}, 'contactsLocationsModule': {'locations': [{'city': 'Arad', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 46.18333, 'lon': 21.31667}}, {'city': 'Bacau', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 46.56718, 'lon': 26.91384}}, {'city': 'Brasov', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 45.64861, 'lon': 25.60613}}, {'city': 'Brăila', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 45.27152, 'lon': 27.97429}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Buzău', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 45.15, 'lon': 26.83333}}, {'city': 'Cluj-Napoca', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'city': 'Floreşti', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 45.05, 'lon': 25.78333}}, {'city': 'Galati', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 45.43687, 'lon': 28.05028}}, {'city': 'Iași', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'city': 'Piteşti', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 44.85, 'lon': 24.86667}}, {'city': 'Ploieşti', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 44.95, 'lon': 26.01667}}, {'city': 'Rm. Valcea', 'country': 'Romania', 'facility': 'Research Site'}, {'city': 'Sibiu', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 45.8, 'lon': 24.15}}, {'city': 'Slatina', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 44.43333, 'lon': 24.36667}}, {'city': 'Târgovişte', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 44.92543, 'lon': 25.4567}}, {'city': 'Tg. Mures', 'country': 'Romania', 'facility': 'Research Site'}, {'city': 'Timișoara', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}, {'city': 'Vanatori(GL)', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 45.73333, 'lon': 27.25}}], 'overallOfficials': [{'name': 'CRISTINA TEODORESCU', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca Pharma SRL Romania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'MC MD', 'oldOrganization': 'AstraZeneca'}}}}