Proton Pump Inhibitor Empirical Treatment in Management of Outpatients With Gastroesophageal Reflux Disease.

AstraZeneca

Status: Completed

Conditions: Patients With Typical Symptoms of GERD (GERD Q >= 8)

Study type: Observational

Funder types: Industry

Identifiers

NCT02606851

D1844R00002

Details and patient eligibility

About

China Survey of Proton Pump Inhibitor Empirical Treatment in Management of Outpatients with Gastroesophageal Reflux Disease

Full description

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.

Enrollment: 1,000 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.