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What is the Predictive Value of the Reflux Impact Scale

NCT00536328 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 938

Last updated 2008-07-09

No results posted yet for this study

Summary

Gastric distress is a common phenomenon in our society. Heartburn and regurgitation occur daily in about 7% of the adult population,weekly 14-20% pf the adults and monthly in 34-44% of adults. The yearly prevalence of recurrent stomach complaints are frequent reason for consulting a primary care physician and are an important reason for using OTC medication. A good diagnosis is important as functional GERD with possible complications such as strictures and Barrett's esophagus or ulcer disease with life threatening complications such as bleeding \& perforations. The clinical diagnosis of reflux disease is mainly based on symptom evaluation. This, however, is hindered by the variety of complaints with different etiology. Treatment with a proton pump inhibitor can be used to confirm the diagnosis reflux disease. A major part of the patients with acid related stomach complaints indeed will experience symptom relief after starting PPI therapy. In this view, it is important to identify these patients who will react on treatment with PPI in quick, accurate, non-invasive and cheap manner. The Reflux Impact Scale (RIS) is validated, short, self explanatory questionnaire which asks for the presence \& impact of reflux symptoms. The RIS is developed for PCP to aid in the evaluation \& selection of these patient who will profit from treatment with PPI. The aim of this present study is to determine which questions of the RIS can be predictive for reaching treatment success with PPI. Treatment success is determined by asking for patients' satisfaction \& completion of the McMaster Overall Treatment Evaluation Heartburn questionnaire.

Conditions

  • Gastroesophageal Reflux Disease
  • GERD
  • Heartburn
  • Acid Regurgitation
  • Retrosternal Pain

Sponsors & Collaborators

Principal Investigators

  • A Sellink · AstraZeneca

  • N van den Berk · AstraZeneca

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Completion
2008-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00536328 on ClinicalTrials.gov