Validation of RDQ Questionnaire
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ClinicalTrials.gov Identifier: NCT00291746 |
Recruitment Status :
Completed
First Posted : February 15, 2006
Last Update Posted : March 12, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastroesophageal Reflux | Drug: Esomeprazole Procedure: Bravo technique | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 350 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Single |
Primary Purpose: | Diagnostic |
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 Start Date : | September 2005 |
Actual Study Completion Date : | November 2006 |

- 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.
- 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)

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Ages Eligible for Study: | 18 Years to 79 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00291746
Canada, Ontario | |
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Etobicoke, Ontario, Canada | |
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Hamilton, Ontario, Canada | |
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North York, Ontario, Canada | |
Canada, Quebec | |
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Mirabel, Quebec, Canada | |
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Pointe-Claire, Quebec, Canada | |
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Saint-Jerome, Quebec, Canada | |
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Saint-Leonard, Quebec, Canada | |
Denmark | |
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Glostrup, Denmark | |
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Herning, Denmark | |
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Odense, Denmark | |
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Randers, Denmark | |
Germany | |
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Berlin, Germany | |
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Bochum, Germany | |
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Dresden, Germany | |
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Garmisch-Partenkirchen, Germany | |
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Halle, Germany | |
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Magdeburg, Germany | |
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Mainz, Germany | |
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München, Germany | |
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Münster, Germany | |
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Siegen, Germany | |
Norway | |
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Bergen, Norway | |
Sweden | |
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Göteborg, Västra Götaland, Sweden | |
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Lund, Sweden | |
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Skövde, Sweden | |
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Stockholm, Sweden | |
United Kingdom | |
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Bicester, United Kingdom | |
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Coventry, United Kingdom | |
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London, United Kingdom | |
Research Site | |
West Bromwich, United Kingdom |
Study Director: | AstraZeneca Nexium Medical Science Director, MD | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00291746 |
Other Study ID Numbers: |
D9914C00002 DIAMOND |
First Posted: | February 15, 2006 Key Record Dates |
Last Update Posted: | March 12, 2009 |
Last Verified: | March 2009 |
GERD |
Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |
Esomeprazole Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |