Validation of RDQ Questionnaire

Gastroesophageal Reflux Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00291746
• Other study ID #: D9914C00002
• Secondary ID: DIAMOND
• Status: Completed
• Phase: Phase 4
• First received: February 14, 2006
• Last updated: March 11, 2009
• Start date: September 2005
• Est. completion date: November 2006

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Drug:
• Esomeprazole

Procedure:
• Bravo technique

Locations

Country	Name	City	State
Canada	Research Site	Etobicoke	Ontario
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Mirabel	Quebec
Canada	Research Site	North York	Ontario
Canada	Research Site	Pointe-Claire	Quebec
Canada	Research Site	Saint-Jerome	Quebec
Canada	Research Site	Saint-Leonard	Quebec
Denmark	Research Site	Glostrup
Denmark	Research Site	Herning
Denmark	Research Site	Odense
Denmark	Research Site	Randers
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
Norway	Research Site	Bergen
Sweden	Research Site	Göteborg	Västra Götaland
Sweden	Research Site	Lund
Sweden	Research Site	Skövde
Sweden	Research Site	Stockholm
United Kingdom	Research Site	Bicester
United Kingdom	Research Site	Coventry
United Kingdom	Research Site	London
United Kingdom	Research Site	West Bromwich

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Canada,  Denmark,  Germany,  Norway,  Sweden,  United Kingdom, 

Outcome

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