Patients With Typical Symptoms of GERD (GERD Q >= 8) Clinical Trial
Official title:
China Survey of Proton Pump Inhibitor Empirical Treatment in Management of Outpatients With Gastroesophageal Reflux Disease
| Verified date | November 2017 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
China Survey of Proton Pump Inhibitor Empirical Treatment in Management of Outpatients with Gastroesophageal Reflux Disease
| Status | Completed |
| Enrollment | 1000 |
| Est. completion date | December 28, 2016 |
| Est. primary completion date | December 28, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Female or male, and any race, Age = 18 years and= 65 outpatients. - 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: - If participating in any interventional clinical trial. - 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | 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 | |
| Secondary | The proportion of patients in each Gerd Q cut-off range at each visit | 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) | |
| Secondary | 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 | |
| Secondary | 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 |