Gastro-Oesophageal Reflux Disease
Conditions
Keywords
heartburn, reflux, proton pump inhibitor, GERD, GORD
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.
Interventions
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed