Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-29 @ 4:18 AM
Study NCT ID:
NCT01200550
Status:
COMPLETED
Last Update Posted:
2012-04-17
First Post:
2010-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Study to Describe Symptom Control and Impact on Daily Life in Gastroesophageal Reflux Disease (GERD) 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1233}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-16', 'studyFirstSubmitDate': '2010-09-07', 'studyFirstSubmitQcDate': '2010-09-10', 'lastUpdatePostDateStruct': {'date': '2012-04-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Epidemiological data: To assess frequency and severity of typical GERD symptoms in newly diagnosed GERD patients and GERD patients with disease duration =3 years', 'timeFrame': 'Maximum of 14 weeks, with 3 visits in total'}, {'measure': 'Epidemiological data: To assess frequency and severity of typical GERD symptoms in newly diagnosed GERD patients and GERD patients with disease duration =3 years', 'timeFrame': 'Visit 1 (enrolment)'}, {'measure': 'Epidemiological data: To assess frequency and severity of typical GERD symptoms in newly diagnosed GERD patients and GERD patients with disease duration =3 years', 'timeFrame': 'Visit 2 (4-6 weeks after Visit 1)'}, {'measure': 'Epidemiological data: To assess frequency and severity of typical GERD symptoms in newly diagnosed GERD patients and GERD patients with disease duration =3 years', 'timeFrame': 'Visit 3 (8-14 weeks after Visit 1).'}], 'secondaryOutcomes': [{'measure': 'The evaluation of GERD Impact Scale (GIS questionnaire) as a useful tool for initial and long term management of GERD patients', 'timeFrame': 'Maximum of 14 weeks, with 3 visits in total: Visit 1 (enrolment), Visit 2 (4-6 weeks after Visit 1) and Visit 3 (8-14 weeks after Visit 1).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gastroesophageal reflux disease', 'GERD Impact Scale'], 'conditions': ['Gastroesophageal Reflux Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate symptoms control and impact on daily life from patients perspective using specific GERD Impact Scale(GIS) questionnaire. The another objective is to obtain local epidemiological data for Bosnia and Herzegovina regarding GERD treatment in primary care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients previously diagnosed with GERD (disease duration =3 years) or newly diagnosed patients that are currently not treted with proton pump inhibitors, for whom GP or specialist (in primary care unit) have previosly decided to initiate or change treatment for GERD.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients previously diagnosed with GERD (disease duration =3 years) or newly diagnosed patients that are currently not treated with proton pump inhibitor, for whom specialist or General Practionaire (GP) have previously decided to initiate or change treatment for GERD; Patients should be treated for GERD according to current practice\n\nExclusion Criteria:\n\n* Females of childbearing potential should not be pregnant or nursing'}, 'identificationModule': {'nctId': 'NCT01200550', 'briefTitle': 'The Study to Describe Symptom Control and Impact on Daily Life in Gastroesophageal Reflux Disease (GERD) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'An Epidemiological, Observational Study to Describe Symptom Control and Impact on Daily Life in Patients With Gastroesophageal Reflux Disease (GERD)', 'orgStudyIdInfo': {'id': 'NIS-GBA-DUM-2010/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Banja Luka', 'country': 'Bosnia and Herzegovina', 'facility': 'Research Site', 'geoPoint': {'lat': 44.77879, 'lon': 17.20629}}, {'city': 'Bijeljina', 'country': 'Bosnia and Herzegovina', 'facility': 'Research Site', 'geoPoint': {'lat': 44.75874, 'lon': 19.21437}}, {'city': 'Derventa', 'country': 'Bosnia and Herzegovina', 'facility': 'Research Site', 'geoPoint': {'lat': 44.97839, 'lon': 17.90779}}, {'city': 'Doboj', 'country': 'Bosnia and Herzegovina', 'facility': 'Research Site', 'geoPoint': {'lat': 44.73179, 'lon': 18.08698}}, {'city': 'Gračanica', 'country': 'Bosnia and Herzegovina', 'facility': 'Research Site', 'geoPoint': {'lat': 44.70307, 'lon': 18.3101}}, {'city': 'Gradačac', 'country': 'Bosnia and Herzegovina', 'facility': 'Research Site', 'geoPoint': {'lat': 44.87851, 'lon': 18.42764}}, {'city': 'Gradiška', 'country': 'Bosnia and Herzegovina', 'facility': 'Research Site', 'geoPoint': {'lat': 45.14484, 'lon': 17.25453}}, {'city': 'Hadžići', 'country': 'Bosnia and Herzegovina', 'facility': 'Research Site', 'geoPoint': {'lat': 43.82222, 'lon': 18.20667}}, {'city': 'Jelah', 'country': 'Bosnia and Herzegovina', 'facility': 'Research Site', 'geoPoint': {'lat': 44.654, 'lon': 17.95897}}, {'city': 'Laktaši', 'country': 'Bosnia and Herzegovina', 'facility': 'Research Site', 'geoPoint': {'lat': 44.90857, 'lon': 17.30135}}, {'city': 'Lukavac', 'country': 'Bosnia and Herzegovina', 'facility': 'Research Site', 'geoPoint': {'lat': 44.54245, 'lon': 18.52618}}, {'city': 'Lukavica', 'country': 'Bosnia and Herzegovina', 'facility': 'Research Site', 'geoPoint': {'lat': 44.76452, 'lon': 18.16887}}, {'city': 'Matuzići', 'country': 'Bosnia and Herzegovina', 'facility': 'Research Site', 'geoPoint': {'lat': 44.68776, 'lon': 18.04885}}, {'city': 'Mostar', 'country': 'Bosnia and Herzegovina', 'facility': 'Research Site', 'geoPoint': {'lat': 43.34333, 'lon': 17.80806}}, {'city': 'Pale', 'country': 'Bosnia and Herzegovina', 'facility': 'Research Site', 'geoPoint': {'lat': 43.81664, 'lon': 18.56949}}, {'city': 'Prijedor', 'country': 'Bosnia and Herzegovina', 'facility': 'Research Site', 'geoPoint': {'lat': 44.97991, 'lon': 16.71401}}, {'city': 'Sarajevo', 'country': 'Bosnia and Herzegovina', 'facility': 'Research Site', 'geoPoint': {'lat': 43.84864, 'lon': 18.35644}}, {'city': 'Trn', 'country': 'Bosnia and Herzegovina', 'facility': 'Research Site', 'geoPoint': {'lat': 44.85829, 'lon': 17.23583}}, {'city': 'Tuzla', 'country': 'Bosnia and Herzegovina', 'facility': 'Research Site', 'geoPoint': {'lat': 44.53842, 'lon': 18.66709}}, {'city': 'Visoko', 'country': 'Bosnia and Herzegovina', 'facility': 'Research Site', 'geoPoint': {'lat': 43.98889, 'lon': 18.17806}}, {'city': 'Vogošća', 'country': 'Bosnia and Herzegovina', 'facility': 'Research Site', 'geoPoint': {'lat': 43.90225, 'lon': 18.34438}}, {'city': 'Zalužani', 'country': 'Bosnia and Herzegovina', 'facility': 'Research Site', 'geoPoint': {'lat': 44.8406, 'lon': 17.22352}}, {'city': 'Živinice', 'country': 'Bosnia and Herzegovina', 'facility': 'Research Site', 'geoPoint': {'lat': 44.44929, 'lon': 18.64978}}], 'overallOfficials': [{'name': 'Srdjan Gornjakovic, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Center University of Sarajevo; Department of Gastrenterology and HepatologySarajevo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}