Proton Pump Inhibitor Empirical Treatment in Management of Outpatients With Gastroesophageal Reflux Disease.
NCT ID: NCT02606851
Last Updated: 2017-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1000 participants
OBSERVATIONAL
2015-12-04
2016-12-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Gastroenterologists already prescribe PPI standard dose bid as empirical treatment.
* GerdQ≥8
* The subject will not have endoscopy within 4 weeks after enrolment.
* Ability to provide informed consent, adhere to the study visit schedule, and complete all study assessments and complete the patient diary by his/herself.
Exclusion Criteria
* Patient with alarm symptom of oncology(weight loss, recurrent dysphagia, anemia, hematemesis, melena).
* Continuous application of nonsteroidal anti-inflammation drugs or acid suppressive drug within 2 weeks before screening.
* 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).
* Previous gastroesophageal surgery.
* Upper gastrointestinal malignancy, achalasia, and esophageal spasm or stricture.
* Peptic ulcer
* Diabetes
* Cerebral vascular disease
* Zollinger-Ellison syndrome
* Scleroderma
* Hiatus hernia women
* Pregnant or lactating women
* Any other subjects were not suitable to this study in the opinion of the investigator.
18 Years
65 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Duowu Zou, leading PI
Role: PRINCIPAL_INVESTIGATOR
Changhai Hospital
Locations
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Research Site
Beijing, , China
Research Site
Benijin, , China
Research Site
Changchun, , China
Research Site
Chongqing, , China
Research Site
Guangzhou, , China
Research Site
Hangzhou, , China
Research Site
Nanjing, , China
Research Site
Shanghai, , China
Research Site
Tianjin, , China
Research Site
Xining, , China
Countries
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Related Links
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GID1844R00002 CSR-Synopsis\_final 1
Other Identifiers
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D1844R00002
Identifier Type: -
Identifier Source: org_study_id