Skip to main content
OpenTrials
Completed

NCT Number: NCT00291746

Validation of RDQ Questionnaire

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastroesophageal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Etobicoke, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Esomeprazole

Drug

Bravo technique

Procedure

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Important dates

Study start
2005
Study completion
2006
First posted
Feb 15, 2006
Registry last updated
Mar 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.