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China Survey of Proton Pump Inhibitor Empirical Treatment in Management of Outpatients with Gastroesophageal Reflux Disease
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.
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| Measure | Description | Time Frame |
|---|---|---|
| The overall responder rate | 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. | After 4 weeks of Proton Pump Inhibitor empirical treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The overall responder rate | The overall responder rate after 2 weeks of Proton Pump Inhibitor empirical treatment | After 2 weeks of Proton Pump Inhibitor empirical treatment |
| The proportion of patients in each Gerd Q cut-off range at each visit |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Duowu Zou, leading PI | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Beijing | China | ||||
| Research Site |
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| Label | URL |
|---|---|
| GID1844R00002 CSR-Synopsis\_final 1 | View source |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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The proportion of patients in each Gerd Q cut-off range at each visit (Gerd Q range: ≤2; 3-7; 8-10; 11-18)
| At each visit (baseline, 2 weeks and 4 weeks) |
| The responder rate of different Proton Pump Inhibitor empirical treatment | The responder rate respectively after 2 and 4 weeks of different Proton Pump Inhibitor empirical treatment | After 2 and 4 weeks of different PPIs empirical treatment |
| The median time to response overall and for different Proton Pump Inhibitor, respectively | 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 | During 4 weeks of whole study |
| 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 |
| D004066 | Digestive System Diseases |