Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-28 @ 11:23 PM
Study NCT ID:
NCT01134367
Status:
COMPLETED
Last Update Posted:
2011-07-14
First Post:
2010-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Epidemiological Study to Describe Symptom Control and Impact of 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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-13', 'studyFirstSubmitDate': '2010-05-28', 'studyFirstSubmitQcDate': '2010-06-01', 'lastUpdatePostDateStruct': {'date': '2011-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Epidemiological data in a population of GERD patients with disease duration ≤ 3 years or newly diagnosed to include: Typical GERD symptoms (indicating frequency and severity of symptoms) and signs', 'timeFrame': '8 weeks'}, {'measure': 'Epidemiological data in a population of GERD patients with disease duration ≤ 3 years or newly diagnosed to include: Demographic data', 'timeFrame': '8 weeks'}, {'measure': 'Epidemiological data in a population of GERD patients with disease duration ≤ 3 years or newly diagnosed to include: Treatments for GERD and treatment changes', 'timeFrame': '8 weeks'}, {'measure': "Epidemiological data in a population of GERD patients with disease duration ≤ 3 years or newly diagnosed to include: Patient's perspective of symptom control and impact on daily life assessed using a patient-questionnaire (GIS-GERD Impact Scale).", 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'To evaluate the added value of a patient questionnaire (GIS-GERD Impact Scale) as a useful tool for the initial and long-term management of GERD patients: determination of the appropriate treatment and evaluation of the response to treatment', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['gastroesophageal reflux disease (GERD)'], 'conditions': ['GERD']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to examine patient's perspective of symptom control and impact of gastroesophageal reflux disease (GERD) on daily life."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'primary care clinics', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with gastroesophageal reflux disease -GERD (disease duration ≤3 years or newly diagnosed) that are currently not treated with a proton pump inhibitor, for whom the general practitioner (GP) has previously decided to initiate or change the tre\n* Patients should be treated for GERD according to current practice (National guideline for treatment of dyspepsia in GP setting)'}, 'identificationModule': {'nctId': 'NCT01134367', 'briefTitle': 'An Epidemiological Study to Describe Symptom Control and Impact of Gastroesophageal Reflux Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': "An Epidemiological, Postmarketing Observational Study to Describe Symptom Control and Impact of Gastroesophageal Reflux Disease (GERD) on Patients' Daily Life", 'orgStudyIdInfo': {'id': 'NIS-GRS-DUM-2010/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients with GERD'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Research Site', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Leskovac', 'country': 'Serbia', 'facility': 'Research Site', 'geoPoint': {'lat': 42.99806, 'lon': 21.94611}}, {'city': 'Niš', 'country': 'Serbia', 'facility': 'Research Site', 'geoPoint': {'lat': 43.32472, 'lon': 21.90333}}, {'city': 'Novi Sad', 'country': 'Serbia', 'facility': 'Research Site', 'geoPoint': {'lat': 45.25167, 'lon': 19.83694}}, {'city': 'Pančevo', 'country': 'Serbia', 'facility': 'Research Site', 'geoPoint': {'lat': 44.87177, 'lon': 20.64167}}, {'city': 'Subotica', 'country': 'Serbia', 'facility': 'Research Site', 'geoPoint': {'lat': 46.1, 'lon': 19.66667}}, {'city': 'Zrenjanin', 'country': 'Serbia', 'facility': 'Research Site', 'geoPoint': {'lat': 45.38361, 'lon': 20.38194}}], 'overallOfficials': [{'name': 'Miodrag Krstić, Prof.Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute for Gastroenterology, Clinical Center of Serbia, Belgrade'}, {'name': 'Dragomir Damjanov, Prof. Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinic for Internal Diseases, Clinical Center of Vojvodina, Novi Sad'}, {'name': 'Aleksandar Nagorni, Prof. Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinic for Internal Diseases- Gastroenterology Dept, Clinical Center Nis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'MC MD', 'oldOrganization': 'AstraZeneca'}}}}