PPI Sequencing Study
Phase 4
Completed
- Conditions
- Gastro-Oesophageal Reflux Disease
- Registration Number
- NCT00384592
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Persisting symptoms of GORD despite previous treatment with a full dose proton pump inhibitor
- Informed consent
- Over 18 years of age
Exclusion Criteria
- Current course of Proton Pump inhibitor treatment for more than 8 weeks prior to enrolment in the study;
- More than 1 other course of PPI treatment in the previous 12 month;
- Previous use of esomeprazole;
- Presence of alarm symptoms.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The primary objective of this study is to assess the change in the frequency of heartburn from baseline value at entry to the end of the study, after 8-weeks treatment with esomeprazole 40mg compared to previous full dose treatment with a PPI daily
- Secondary Outcome Measures
Name Time Method Change in frequency and severity of heartburn, epigastric pain and acid regurgitation after 4 and 8 weeks treatment from baseline value at study entry Change in symptom control from baseline to 4 and 8 weeks using QOL questionnaires
Trial Locations
- Locations (2)
Research Site
🇬🇧Warminster, United Kingdom
Research SIte
🇬🇧Glasgow, United Kingdom