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

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

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

Study Overview

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

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• China
  • 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
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Duowu Zou, leading PI, Changhai hospital

Publications and helpful links

Helpful Links

• GID1844R00002 CSR-Synopsis_final 1

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2015
• Primary Completion (Actual): December 28, 2016
• Study Completion (Actual): December 28, 2016

Study Registration Dates

• First Submitted: November 16, 2015
• First Submitted That Met QC Criteria: November 16, 2015
• First Posted (Estimate): November 17, 2015

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 14, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Proton Pump Inhibitor, GERD, GERD Q
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: D1844R00002