What is the Predictive Value of the Reflux Impact Scale

NCT00536328 | Terminated

• 1 other identifier: NL401611
• Study Type: observational
• Target: 938
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Reflux Impact Scale (RIS); predictive value; treatment success; patient satisfaction; proton pump inhibitor; gastro-esophageal reflux disease; PPU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting at general practitioner

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Gastroesophageal Reflux; Heartburn; Patient Satisfaction

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• A Sellink

  AstraZeneca

  STUDY DIRECTOR

• N van den Berk

  AstraZeneca

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 26, 2007
• First Posted: September 27, 2007
• Study Start: October 1, 2007
• Study Completion: June 1, 2008
• Last Updated: July 9, 2008

Record last verified: 2008-07