Validation of RDQ Questionnaire

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00291746
First received: February 14, 2006
Last updated: March 11, 2009
Last verified: March 2009

February 14, 2006
March 11, 2009
September 2005
Not Provided
  • 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.
Same as current
Complete list of historical versions of study NCT00291746 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
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.

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
Gastroesophageal Reflux
  • Drug: Esomeprazole
  • Procedure: Bravo technique
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
350
November 2006
Not Provided

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)
Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Canada,   Denmark,   United Kingdom,   Norway,   Sweden
 
NCT00291746
D9914C00002, DIAMOND
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: AstraZeneca Nexium Medical Science Director, MD AstraZeneca
AstraZeneca
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP