Gastroesophageal Reflux
Conditions
Keywords
GERD
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.
Interventions
DRUGEsomeprazole
PROCEDUREBravo technique
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome of PPI test (is assessed between visit 3.2 and 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) | — |
| Selection of RDQ items (RDQ will be completed by subject at Screening and visit 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
| 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) | — |
Countries
Canada, Denmark, Germany, Norway, Sweden, United Kingdom
Outcome results
None listed