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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00536328 |
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 |
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Gastroesophageal Reflux Disease GERD Heartburn Acid Regurgitation Retrosternal Pain |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | What is the Value of the Use of Validated Questionnaire (Reflux Impact Scale) for Predicting Treatment Success With PPI |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients presenting at general practitioner
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | NL401611 |
Study First Received: | September 26, 2007 |
Last Updated: | July 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00536328 History of Changes |
Health Authority: | Not required for this study: |
Reflux Impact Scale (RIS) predictive value treatment success patient satisfaction |
proton pump inhibitor gastro-esophageal reflux disease PPU |
Pyrosis Signs and Symptoms, Digestive Gastrointestinal Diseases Pain Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders |
Signs and Symptoms Digestive System Diseases Proton Pump Inhibitors Esophageal Disorder Heartburn Esophageal Diseases |
Deglutition Disorders Esophageal Motility Disorders Signs and Symptoms Digestive System Diseases Signs and Symptoms, Digestive |
Gastrointestinal Diseases Heartburn Esophageal Diseases Gastroesophageal Reflux |