Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-31 @ 5:47 PM
Study NCT ID:
NCT01635959
Status:
COMPLETED
Last Update Posted:
2014-10-03
First Post:
2012-07-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Gastroesophageal Reflux Disease (GERD) in Patients With Upper Gastrointestinal Tract Symptoms in Egypt
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': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3170}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-02', 'studyFirstSubmitDate': '2012-07-03', 'studyFirstSubmitQcDate': '2012-07-09', 'lastUpdatePostDateStruct': {'date': '2014-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients scoring ≥ 8 in GERD-Q', 'timeFrame': 'baseline', 'description': 'Percentage of patients scoring ≥ 8 in GERD-Q will be considered as suffering from GERD.\n\nThe GERD-Q is a potentially useful tool for family practitioners and other health care professionals in diagnosing and managing GERD without initial specialist referral or endoscopy.\n\nThe Egyptian-validated version of the GERD-Q will be used for the study purposes.'}], 'secondaryOutcomes': [{'measure': 'Socio-demographic characteristics of patients diagnosed with gastroesophageal reflux disease (GERD)', 'timeFrame': 'baseline', 'description': 'Descriptive analysis of socio-demographic characteristics of patients diagnosed with gastroesophageal reflux disease (GERD) in Egypt.'}, {'measure': 'Treatment patterns in patients diagnosed with gastroesophageal reflux disease (GERD)', 'timeFrame': 'baseline', 'description': 'Descriptive analysis of treatment patterns in patients diagnosed with gastroesophageal reflux disease (GERD) in Egypt.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['upper gastro-intestinal symptoms, GERD'], 'conditions': ['Patients With Upper Gastro-intestinal Symptoms']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to calculate the prevalence of gastroesophageal reflux disease (GERD) by mean of GERD-Q questionnaire in patients with upper gastrointestinal tract symptoms in Egypt.', 'detailedDescription': 'Prevalence of Gastroesophageal reflux disease (GERD) in patients with upper gastrointestinal tract symptoms in Egypt'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Community patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and above\n* Attending the medical office and reporting symptoms suggestive of upper gastrointestinal tract symptoms such as heartburn/regurgitation, abdominal pain, bloating, belching and nausea/vomiting.\n\nExclusion Criteria:\n\n* Participating on a clinical trial during the last 3 months.\n* Patients not able to read and/or understand the GERD-Q questionnaire.\n* Patients already included in the study in other participating site.\n* Patients taking PPIs or H2blockers in the l'}, 'identificationModule': {'nctId': 'NCT01635959', 'acronym': 'GERD Q NIS', 'briefTitle': 'Prevalence of Gastroesophageal Reflux Disease (GERD) in Patients With Upper Gastrointestinal Tract Symptoms in Egypt', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Prevalence of Gastroesophageal Reflux Disease (GERD) in Patients With Upper Gastrointestinal Tract Symptoms in Egypt', 'orgStudyIdInfo': {'id': 'NIS-GEG-XXX-2012/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Gastrointestinal Trackt Symptoms'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Research Site', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}, {'city': 'Al Menia', 'country': 'Egypt', 'facility': 'Research Site'}, {'city': 'Alex', 'country': 'Egypt', 'facility': 'Research Site'}, {'city': 'Asuit', 'country': 'Egypt', 'facility': 'Research Site'}, {'city': 'Aswān', 'country': 'Egypt', 'facility': 'Research Site', 'geoPoint': {'lat': 24.09082, 'lon': 32.89942}}, {'city': 'Banhā', 'country': 'Egypt', 'facility': 'Research Site', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Research Site', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Domiaat', 'country': 'Egypt', 'facility': 'Research Site'}, {'city': 'Hurghada', 'country': 'Egypt', 'facility': 'Research Site', 'geoPoint': {'lat': 27.25738, 'lon': 33.81291}}, {'city': 'Ismailia', 'country': 'Egypt', 'facility': 'Research Site', 'geoPoint': {'lat': 30.60427, 'lon': 32.27225}}, {'city': 'Kafr ash Shaykh', 'country': 'Egypt', 'facility': 'Research Site', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}, {'city': 'Kalubia', 'country': 'Egypt', 'facility': 'Research Site'}, {'city': 'Luxor', 'country': 'Egypt', 'facility': 'Research Site', 'geoPoint': {'lat': 25.69893, 'lon': 32.6421}}, {'city': 'Mahala', 'country': 'Egypt', 'facility': 'Research Site'}, {'city': 'Menofia', 'country': 'Egypt', 'facility': 'Research Site'}, {'city': 'Port-Saeed', 'country': 'Egypt', 'facility': 'Research Site'}, {'city': 'Qina', 'country': 'Egypt', 'facility': 'Research Site', 'geoPoint': {'lat': 26.16418, 'lon': 32.72671}}, {'city': 'Sharkiah', 'country': 'Egypt', 'facility': 'Research Site'}, {'city': 'Sohag', 'country': 'Egypt', 'facility': 'Research Site', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}, {'city': 'Suiz', 'country': 'Egypt', 'facility': 'Research Site'}, {'city': 'Tanta', 'country': 'Egypt', 'facility': 'Research Site', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'Dina A Ahmed, MD', 'role': 'STUDY_DIRECTOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}