Validation of RDQ Questionnaire
A Single-Blind Single Arm Study to Validate the Reflux Disease Questionnaire (RDQ) for the Diagnosis of Reflux Disease in Primary Care in Patients Treated With Esomeprazole 40 mg o.d.
2 other identifiers
interventional
350
6 countries
30
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 be compared with other established approaches to the diagnosis of gastroesophageal reflux disease (GERD) in a primary care patient population with symptoms thought to be of upper gastrointestinal (GI) tract origin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2005
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 14, 2006
CompletedFirst Posted
Study publicly available on registry
February 15, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedMarch 12, 2009
March 1, 2009
February 14, 2006
March 11, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Selection of RDQ items (RDQ will be completed by subject at Screening and visit 4)
Presence/absence of GERD as assessed by endoscopic Los Angeles (LA) grade (gastroesophageal endoscopy will be performed at visit 2)
pH monitoring (% time with esophageal pH<4; Bravo pH-Monitoring will be performed from visit 2 to 3.1)
Symptom Associated Probability (outcome test for Bravo pH monitoring)
Outcome of PPI test (is assessed between visit 3.2 and 4.
Secondary Outcomes (3)
Mean item score for the GSRS dimensions at the initial and last visit (as assessed by answers of patient at visit 1 and visit 4)
RDQ item scores and RDQ mean item scores for RDQ dimensions at baseline and at the end of treatment (as assessed by answers of patient at Screening and visit 4)
Occurrence and severity of clinical symptoms at the initial and last visit (as reported by the subject)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (30)
Research Site
Etobicoke, Ontario, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
North York, Ontario, Canada
Research Site
Mirabel, Quebec, Canada
Research Site
Pointe-Claire, Quebec, Canada
Research Site
Saint-Jérôme, Quebec, Canada
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Saint-Léonard, Quebec, Canada
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Glostrup Municipality, Denmark
Research Site
Herning, Denmark
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Odense, Denmark
Research Site
Randers, Denmark
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Berlin, Germany
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Bochum, Germany
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Dresden, Germany
Research Site
Garmisch-Partenkirchen, Germany
Research Site
Halle, Germany
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Magdeburg, Germany
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Mainz, Germany
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München, Germany
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Münster, Germany
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Siegen, Germany
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Bergen, Norway
Research Site
Gothenburg, Västra Götaland County, Sweden
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Lund, Sweden
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Skövde, Sweden
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Stockholm, Sweden
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Bicester, United Kingdom
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Coventry, United Kingdom
Research Site
London, United Kingdom
Research Site
West Bromwich, United Kingdom
Related Publications (3)
Vakil N, Niklasson A, Denison H, Ryden A. Symptom profile in partial responders to a proton pump inhibitor compared with treatment-naive patients with gastroesophageal reflux disease: a post hoc analysis of two study populations. BMC Gastroenterol. 2014 Oct 10;14:177. doi: 10.1186/1471-230X-14-177.
PMID: 25304129DERIVEDBytzer P, Jones R, Vakil N, Junghard O, Lind T, Wernersson B, Dent J. Limited ability of the proton-pump inhibitor test to identify patients with gastroesophageal reflux disease. Clin Gastroenterol Hepatol. 2012 Dec;10(12):1360-6. doi: 10.1016/j.cgh.2012.06.030. Epub 2012 Jul 17.
PMID: 22813439DERIVEDDent J, Vakil N, Jones R, Bytzer P, Schoning U, Halling K, Junghard O, Lind T. Accuracy of the diagnosis of GORD by questionnaire, physicians and a trial of proton pump inhibitor treatment: the Diamond Study. Gut. 2010 Jun;59(6):714-21. doi: 10.1136/gut.2009.200063.
PMID: 20551454DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Nexium Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 14, 2006
First Posted
February 15, 2006
Study Start
September 1, 2005
Study Completion
November 1, 2006
Last Updated
March 12, 2009
Record last verified: 2009-03