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Validation of RDQ Questionnaire

Primary Purpose

Gastroesophageal Reflux

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Esomeprazole
Bravo technique
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastroesophageal Reflux focused on measuring GERD

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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Outcomes

Primary Outcome Measures

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 Outcome Measures

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)

Full Information

First Posted
February 14, 2006
Last Updated
March 11, 2009
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00291746
Brief Title
Validation of RDQ Questionnaire
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 Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux
Keywords
GERD

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Non-Randomized
Enrollment
350 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Intervention Type
Procedure
Intervention Name(s)
Bravo technique
Primary Outcome Measure Information:
Title
Selection of RDQ items (RDQ will be completed by subject at Screening and visit 4)
Title
Presence/absence of GERD as assessed by endoscopic Los Angeles (LA) grade (gastroesophageal endoscopy will be performed at visit 2)
Title
pH monitoring (% time with esophageal pH<4; Bravo pH-Monitoring will be performed from visit 2 to 3.1)
Title
Symptom Associated Probability (outcome test for Bravo pH monitoring)
Title
Outcome of PPI test (is assessed between visit 3.2 and 4.
Secondary Outcome Measure Information:
Title
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)
Title
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)
Title
Occurrence and severity of clinical symptoms at the initial and last visit (as reported by the subject)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Nexium Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Etobicoke
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
North York
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Mirabel
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Pointe-Claire
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Saint-Jerome
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Saint-Leonard
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Glostrup
Country
Denmark
Facility Name
Research Site
City
Herning
Country
Denmark
Facility Name
Research Site
City
Odense
Country
Denmark
Facility Name
Research Site
City
Randers
Country
Denmark
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Bochum
Country
Germany
Facility Name
Research Site
City
Dresden
Country
Germany
Facility Name
Research Site
City
Garmisch-Partenkirchen
Country
Germany
Facility Name
Research Site
City
Halle
Country
Germany
Facility Name
Research Site
City
Magdeburg
Country
Germany
Facility Name
Research Site
City
Mainz
Country
Germany
Facility Name
Research Site
City
München
Country
Germany
Facility Name
Research Site
City
Münster
Country
Germany
Facility Name
Research Site
City
Siegen
Country
Germany
Facility Name
Research Site
City
Bergen
Country
Norway
Facility Name
Research Site
City
Göteborg
State/Province
Västra Götaland
Country
Sweden
Facility Name
Research Site
City
Lund
Country
Sweden
Facility Name
Research Site
City
Skövde
Country
Sweden
Facility Name
Research Site
City
Stockholm
Country
Sweden
Facility Name
Research Site
City
Bicester
Country
United Kingdom
Facility Name
Research Site
City
Coventry
Country
United Kingdom
Facility Name
Research Site
City
London
Country
United Kingdom
Facility Name
Research Site
City
West Bromwich
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25304129
Citation
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.
Results Reference
derived
PubMed Identifier
22813439
Citation
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.
Results Reference
derived
PubMed Identifier
20551454
Citation
Dent 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.
Results Reference
derived

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Validation of RDQ Questionnaire

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