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Clinical Trials/NCT01432392
NCT01432392CompletedNot Applicable

A Prospective, Observational Study to Describe Symptom Control and Impact on Daily Life in Patients With Gastroesophageal Reflux Disease (GERD)

AstraZeneca0 sites1,000 target enrollmentStarted: September 2011Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,000
Primary Endpoint
Percent change in intensity and frequency for each of typical GERD symptoms from baseline to week 4-6
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Percent change in intensity and frequency for each of typical GERD symptoms from baseline to week 4-6

Time Frame: Day 0 to week 4-6

Changes in GERD questionnaire(GERD-Q) scores from baseline to week 4-6

Time Frame: Day 0 to week 4-6

Secondary Outcomes

  • To evaluate the correlation between GERD-Q scores and symptom scores(two times)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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