Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-02-22 @ 7:01 AM
Study NCT ID:
NCT02606851
Status:
COMPLETED
Last Update Posted:
2017-11-17
First Post:
2015-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proton Pump Inhibitor Empirical Treatment in Management of Outpatients 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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2016-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-14', 'studyFirstSubmitDate': '2015-11-16', 'studyFirstSubmitQcDate': '2015-11-16', 'lastUpdatePostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The overall responder rate', 'timeFrame': 'After 4 weeks of Proton Pump Inhibitor empirical treatment', 'description': 'The overall responder rate after 4 weeks of Proton Pump Inhibitor empirical treatment. Responder is defined as heartburn/regurgitation frequency ≤1 days during 7 days before evaluation visit, assessed using Gerd Q questionnaire at each post-baseline visit.'}], 'secondaryOutcomes': [{'measure': 'The overall responder rate', 'timeFrame': 'After 2 weeks of Proton Pump Inhibitor empirical treatment', 'description': 'The overall responder rate after 2 weeks of Proton Pump Inhibitor empirical treatment'}, {'measure': 'The proportion of patients in each Gerd Q cut-off range at each visit', 'timeFrame': 'At each visit (baseline, 2 weeks and 4 weeks)', 'description': 'The proportion of patients in each Gerd Q cut-off range at each visit (Gerd Q range: ≤2; 3-7; 8-10; 11-18)'}, {'measure': 'The responder rate of different Proton Pump Inhibitor empirical treatment', 'timeFrame': 'After 2 and 4 weeks of different PPIs empirical treatment', 'description': 'The responder rate respectively after 2 and 4 weeks of different Proton Pump Inhibitor empirical treatment'}, {'measure': 'The median time to response overall and for different Proton Pump Inhibitor, respectively', 'timeFrame': 'During 4 weeks of whole study', 'description': "The median time to response (heartburn/regurgitation frequency ≤1 days during last 7 days assessed using patient's diary card) overall and for different Proton Pump Inhibitor, respectively"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Proton Pump Inhibitor, GERD, GERD Q'], 'conditions': ['Patients With Typical Symptoms of GERD (GERD Q >= 8)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3946&filename=GID1844R00002_CSR-Synopsis_final_1.pdf', 'label': 'GID1844R00002 CSR-Synopsis\\_final 1'}]}, 'descriptionModule': {'briefSummary': 'China Survey of Proton Pump Inhibitor Empirical Treatment in Management of Outpatients with Gastroesophageal Reflux Disease', 'detailedDescription': 'To estimate the overall responder rate after 4 weeks of Proton Pump Inhibitor empirical treatment This will be a multicenter prospective observational study carried out in China. Investigator will collect data in a pre-specified Case Report Form from the outpatient. Informed consents will be needed. Investigator will provide patient diary card to each patient for them to note down the symptom frequency every day. Main data from each outpatient will include demographics, Gerd Q, symptom frequency and Proton Pump Inhibitor empirical treatment. Data from each outpatient will be collected on the screening day, 2 weeks and 4 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The subject population that will be included in the NIS are the consecutive outpatients between 18 and 65 years old with Gerd Q ≥ 8, who will not have endoscopy within 4 weeks while gastroenterologists already prescribe PPI as empirical treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female or male, and any race, Age ≥ 18 years and≤ 65 outpatients.\n* Gastroenterologists already prescribe PPI standard dose bid as empirical treatment.\n* GerdQ≥8\n* The subject will not have endoscopy within 4 weeks after enrolment.\n* Ability to provide informed consent, adhere to the study visit schedule, and complete all study assessments and complete the patient diary by his/herself.\n\nExclusion Criteria:\n\n* If participating in any interventional clinical trial.\n* Patient with alarm symptom of oncology(weight loss, recurrent dysphagia, anemia, hematemesis, melena).\n* Continuous application of nonsteroidal anti-inflammation drugs or acid suppressive drug within 2 weeks before screening.\n* The need for H2-receptor antagonists (H2RA) including cimetidine, ranitidine and famotidine or sucralfate, antacids, traditional Chinese medicine and prokinetics during the upcoming 4 weeks (study duration).\n* Previous gastroesophageal surgery.\n* Upper gastrointestinal malignancy, achalasia, and esophageal spasm or stricture.\n* Peptic ulcer\n* Diabetes\n* Cerebral vascular disease\n* Zollinger-Ellison syndrome\n* Scleroderma\n* Hiatus hernia women\n* Pregnant or lactating women\n* Any other subjects were not suitable to this study in the opinion of the investigator.'}, 'identificationModule': {'nctId': 'NCT02606851', 'briefTitle': 'Proton Pump Inhibitor Empirical Treatment in Management of Outpatients With Gastroesophageal Reflux Disease.', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'China Survey of Proton Pump Inhibitor Empirical Treatment in Management of Outpatients With Gastroesophageal Reflux Disease', 'orgStudyIdInfo': {'id': 'D1844R00002'}}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Benijin', 'country': 'China', 'facility': 'Research Site'}, {'city': 'Changchun', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Chongqing', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Guangzhou', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Hangzhou', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Nanjing', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Tianjin', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Xining', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 36.62554, 'lon': 101.75739}}], 'overallOfficials': [{'name': 'Duowu Zou, leading PI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changhai Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}