Validation of RDQ Questionnaire

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Gastroesophageal Reflux	Drug: Esomeprazole; Procedure: Bravo technique	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	350 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	Single
Primary Purpose:	Diagnostic
Official Title:	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.
Study Start Date :	September 2005
Actual Study Completion Date :	November 2006

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Selection of RDQ items (RDQ will be completed by subject at Screening and visit 4)
2. Presence/absence of GERD as assessed by endoscopic Los Angeles (LA) grade (gastroesophageal endoscopy will be performed at visit 2)
3. pH monitoring (% time with esophageal pH<4; Bravo pH-Monitoring will be performed from visit 2 to 3.1)
4. Symptom Associated Probability (outcome test for Bravo pH monitoring)
5. Outcome of PPI test (is assessed between visit 3.2 and 4.

Secondary Outcome Measures :

1. 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)
2. 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)
3. Occurrence and severity of clinical symptoms at the initial and last visit (as reported by the subject)

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 79 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)

Contacts and Locations

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Locations

Canada, Ontario
Research Site
Etobicoke, Ontario, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
North York, Ontario, Canada
Canada, Quebec
Research Site
Mirabel, Quebec, Canada
Research Site
Pointe-Claire, Quebec, Canada
Research Site
Saint-Jerome, Quebec, Canada
Research Site
Saint-Leonard, Quebec, Canada
Denmark
Research Site
Glostrup, Denmark
Research Site
Herning, Denmark
Research Site
Odense, Denmark
Research Site
Randers, Denmark
Germany
Research Site
Berlin, Germany
Research Site
Bochum, Germany
Research Site
Dresden, Germany
Research Site
Garmisch-Partenkirchen, Germany
Research Site
Halle, Germany
Research Site
Magdeburg, Germany
Research Site
Mainz, Germany
Research Site
München, Germany
Research Site
Münster, Germany
Research Site
Siegen, Germany
Norway
Research Site
Bergen, Norway
Sweden
Research Site
Göteborg, Västra Götaland, Sweden
Research Site
Lund, Sweden
Research Site
Skövde, Sweden
Research Site
Stockholm, Sweden
United Kingdom
Research Site
Bicester, United Kingdom
Research Site
Coventry, United Kingdom
Research Site
London, United Kingdom
Research Site
West Bromwich, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	AstraZeneca Nexium Medical Science Director, MD	AstraZeneca

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Vakil N, Niklasson A, Denison H, Rydén A. Symptom profile in partial responders to a proton pump inhibitor compared with treatment-naïve 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.

Bytzer 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.

Dent J, Vakil N, Jones R, Bytzer P, Schöning 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.

ClinicalTrials.gov Identifier:	NCT00291746 History of Changes
Other Study ID Numbers:	D9914C00002; DIAMOND
First Posted:	February 15, 2006
Last Update Posted:	March 12, 2009
Last Verified:	March 2009

Keywords provided by AstraZeneca:

GERD

Additional relevant MeSH terms:

Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases	Esomeprazole; Anti-Ulcer Agents; Gastrointestinal Agents; Proton Pump Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action