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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00384592 |
The purpose of this study is to assess how patients with gastro-oesophageal reflux disease (heartburn) who are currently receiving treatment with a proton pump inhibitor but are still experiencing symptoms will benefit from a change in treatment.
Condition | Intervention | Phase |
---|---|---|
Gastro-Oesophageal Reflux Disease |
Drug: Esomeprazole Procedure: Physical exam Procedure: Pregnancy test if applicable |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Study to Assess the Effectiveness of Esomeprazole 40 mg Once Daily in Subjects With Continuing Gastroesophageal Reflux Disease (GORD) Symptoms Following Treatment Wit a Previous Full Dose Proton Pump Inhibitor (PPI) |
Estimated Enrollment: | 100 |
Study Start Date: | September 2006 |
Study Completion Date: | June 2007 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |
Research Site | |
FOWEY, United Kingdom | |
Research Site | |
HAMILTON, United Kingdom | |
Research Site | |
MOTHERWELL, United Kingdom | |
Research Site | |
WARMINSTER, United Kingdom | |
Research Site | |
ALLERTON, United Kingdom | |
Research Site | |
ASHFORD, United Kingdom | |
Research Site | |
ATHERSTONE, United Kingdom | |
Research Site | |
STEVENAGE, United Kingdom | |
Research Site | |
BATH, United Kingdom | |
Research Site | |
BLACKPOOL, United Kingdom | |
Research SIte | |
BOLTON, United Kingdom | |
Research Site | |
COVENTRY, United Kingdom | |
Research SIte | |
GLASGOW, United Kingdom | |
Research Site | |
AYRSHIRE, United Kingdom |
Study Director: | Rhiannon Rowsell, MD | AstraZeneca |
Principal Investigator: | Roger Jones, MD | UCL |
Study ID Numbers: | D9612L00104 |
Study First Received: | October 5, 2006 |
Last Updated: | February 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00384592 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
heartburn reflux proton pump inhibitor GERD GORD |
Deglutition Disorders Esophageal Motility Disorders Pyrosis Digestive System Diseases Esophageal disorder |
Gastrointestinal Diseases Heartburn Omeprazole Esophageal Diseases Gastroesophageal Reflux |
Molecular Mechanisms of Pharmacological Action Therapeutic Uses Anti-Ulcer Agents |
Gastrointestinal Agents Enzyme Inhibitors Pharmacologic Actions |