PREDICT: What is the Predictive Value of the Reflux Impact Scale

Sponsor

AstraZeneca (Industry)

Overall Status

Terminated

CT.gov ID

NCT00536328

Collaborator

(none)

938

Enrollment

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux Disease GERD Heartburn Acid Regurgitation Retrosternal Pain

Study Design

Study Type:

Observational

Anticipated Enrollment :

938 participants

Time Perspective:

Prospective

Official Title:

What is the Value of the Use of Validated Questionnaire (Reflux Impact Scale) for Predicting Treatment Success With PPI

Study Start Date :

Oct 1, 2007

Actual Study Completion Date :

Jun 1, 2008

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18 years or older
Patients with symptoms of reflux disease and or regurgitation and/or retrosternal pain probably caused by acid during the previous 7 days and for which treatment with a PPI is started.