Status:
COMPLETED
Validation of RDQ Questionnaire
Lead Sponsor:
AstraZeneca
Conditions:
Gastroesophageal Reflux
Eligibility:
All Genders
18-79 years
Phase:
PHASE4
Brief Summary
The primary objective of this study is to determine the accuracy of the Reflux Disease Questionnaire (RDQ) as a diagnostic test for gastroesophageal reflux disease. Symptom evaluation by the RDQ will ...
Eligibility Criteria
Inclusion
- Subjects who seek medical advice at their family doctor (primary care physician) for symptoms thought by the primary care physician to arise from the upper GI tract
- The symptoms thought to pertain to the upper GI tract must have been present for at least 4 weeks prior to Visit 1 and to have occurred at least twice a week during that period
- The symptoms thought to pertain to the upper GI tract must have been of at least mild severity for a minimum of 3 days during the week prior to Visit 1
Exclusion
- Upper GI endoscopy performed within a year prior to Visit 1
- Previous anti-reflux surgery, surgery for peptic ulcer or any form of upper gastrointestinal resective surgery
- Contra-indication to the Bravo™ procedure such as subjects with a history of bleeding diathesis, strictures anywhere along the GI-tract, esophageal varices, obstructions, or subjects equipped with a pacemaker, an implantable cardiac defibrillator or an implantable neurostimulator (NB: subjects with severe esophagitis (grade D) confirmed by endoscopy at Visit 2 can continue the study without performing the Bravo™ procedure)
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT00291746
Start Date
September 1 2005
End Date
November 1 2006
Last Update
March 12 2009
Active Locations (30)
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1
Research Site
Etobicoke, Ontario, Canada
2
Research Site
Hamilton, Ontario, Canada
3
Research Site
North York, Ontario, Canada
4
Research Site
Mirabel, Quebec, Canada