Multi-Center Study of Panosyl-Isomaltooligosaccharides Adjunctive to PPI Therapy to Treat GERD
NCT05556824
Deglutition Disorders, Digestive System Diseases
Phoenix, Arizona, United States
View Trial DetailsNCT Number: NCT02606851
China Survey of Proton Pump Inhibitor Empirical Treatment in Management of Outpatients with Gastroesophageal Reflux Disease
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Notify Me18 year–65 year
All sexes
Observational
Research Site, Beijing, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: After 4 weeks of Proton Pump Inhibitor empirical treatment
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.
Time frame: After 2 weeks of Proton Pump Inhibitor empirical treatment
The overall responder rate after 2 weeks of Proton Pump Inhibitor empirical treatment
Time frame: At each visit (baseline, 2 weeks and 4 weeks)
The proportion of patients in each Gerd Q cut-off range at each visit (Gerd Q range: ≤2; 3-7; 8-10; 11-18)
Time frame: After 2 and 4 weeks of different PPIs empirical treatment
The responder rate respectively after 2 and 4 weeks of different Proton Pump Inhibitor empirical treatment
Time frame: During 4 weeks of whole study
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
AstraZeneca
Industry
China Survey of Proton Pump Inhibitor Empirical Treatment in Management of Outpatients With Gastroesophageal Reflux Disease
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