What is the Predictive Value of the Reflux Impact Scale

Gastroesophageal Reflux Disease Clinical Trial

— PREDICT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00536328
• Other study ID #: NL401611
• Status: Terminated
• Phase: N/A
• First received: September 26, 2007
• Last updated: July 7, 2008
• Start date: October 2007
• Est. completion date: June 2008

Study information

• Verified date: July 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Not required for this study:
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 938
• Est. completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Exclusion Criteria:

• Use of PPI and/or H2-receptor antagonist in the month prior to participation in this study.

• Presence of alarm symptoms

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca