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What is the Predictive Value of the Reflux Impact Scale (PREDICT)

This study has been terminated.
(due to very low recruitment. For this reason, there will be no further analysis and reporting of this study.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00536328
First Posted: September 27, 2007
Last Update Posted: July 9, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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
Gastroesophageal Reflux Disease GERD Heartburn Acid Regurgitation Retrosternal Pain

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: What is the Value of the Use of Validated Questionnaire (Reflux Impact Scale) for Predicting Treatment Success With PPI

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Estimated Enrollment: 938
Study Start Date: October 2007
Study Completion Date: June 2008
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting at general practitioner
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00536328


Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: A Sellink AstraZeneca
Study Chair: N van den Berk AstraZeneca
  More Information

ClinicalTrials.gov Identifier: NCT00536328     History of Changes
Other Study ID Numbers: NL401611
First Submitted: September 26, 2007
First Posted: September 27, 2007
Last Update Posted: July 9, 2008
Last Verified: July 2008

Keywords provided by AstraZeneca:
Reflux Impact Scale (RIS)
predictive value
treatment success
patient satisfaction
proton pump inhibitor
gastro-esophageal reflux disease
PPU

Additional relevant MeSH terms:
Gastroesophageal Reflux
Heartburn
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms