Symptom Control and Impact on Daily Life in Patients With Gastroesophageal Reflux Disease

Completed

• Conditions: Gastroesophageal Reflux Disease

• Registration Number: NCT01432392
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to evaluate the impact of gastroesophageal reflux disease (GERD) treatment in primary care setting on symptom control and daily life in symptomatic GERD patients, using both GERD questionnaire and clinical symptoms assessment

Detailed Description

A prospective, observational study to describe symptom control and impact on daily life in patients with gastroesophageal reflux disease (GERD)

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-09
• Study First Submitted QC: 2011-09-12
• Study First Posted: 2011-09-13
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-09
• Last Update Posted: 2012-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Patients known or newly diagnosed with GERD
• Patients with typical GERD symptoms as heartburn and regurgitation for ≥2 days in the previous week
• Patients, currently not treated with a proton pump inhibitor

Exclusion Criteria

• Patients who have been receiving treatment with non-steroidal antiinflammatory drugs within two weeks prior the inclusion in the study
• Patients with medical history of surgery of the esophagus, stomach or duodenum
• Pregnant or nursing females

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent change in intensity and frequency for each of typical GERD symptoms from baseline to week 4-6	Day 0 to week 4-6
Changes in GERD questionnaire(GERD-Q) scores from baseline to week 4-6	Day 0 to week 4-6

Secondary Outcome Measures

Name	Time	Method
To evaluate the correlation between GERD-Q scores and symptom scores	two times