The Rabeprazole and Esomeprazole Reflux Assessment Trial

INTERVENTION: Subjects will be randomised to receive oral treatment with either 20mg Rabeprazole Sodium (PARIET), 20mg Esomeprazole (NEXIUM) or 40mg Esomeprazole (NEXIUM) once daily for 4 weeks. There is no control group all treatments are currently marketing active interventions. CONDITION: Gastro‐oesophageal reflux disease PRIMARY OUTCOME: The primary objective of this study is to compare in a non‐inferiority design, the number of subjects with heartburn and regurgitation symptom resolution after 4 weeks of treatment with either rabeprazole 20mg, esomeprazole 20mg or esomeprazole 40mg. The degree of resolution will be defined as follows: ; 1. Complete resolution is the absence of symptoms for any 7 consecutive days within the 4 week period ; 2. Satisfactory resolution is a reduction in symptom severity from moderate, severe or very severe to mild, very mild or none at any time within the 4 week period. SECONDARY OUTCOME: 1. Comparison of the number of subjects in each treatment group with resolution of other GORD symptoms, measured daily (fullness/ early satiety, nausea/ vomiting, bloating, upper abdominal pain and lower abdominal pain) where the degree of resolution will be defined as Complete or Satisfactory Resolution. 2. Comparison of the median time to first symptom resolution 3. Comparison of the number of heartburn and regurgitation symptom free days 4. Evaluation of the severity of symptoms during treatment. 5. Comparison of changes in Quality of Life between the three treatment groups. 6. Comparison of subject and investigator satisfaction. 7. Analysis of factors predictive of outcomes· 8. Evaluation of safety and tolerability of treatments INCLUSION CRITERIA: 1. Able to give written informed consent. 2. Heartburn (defined as a feeling of burning or pain, rising from the epigastrium or lower part of the chest up towards the neck) with or without regurgitation. To be eligible, subjects must have had episodes of heartburn with or without regurgitation for 3 months or longer, and for > 3 days in the 7 days prior to randomisation. 3. Able to understand and complete questionnaires and have access to a telephone. 4. Helicobacter pylori testing is allowed provided that it is not critical to a PPI‐prescribing decision and(a) The results of the test must not be divulged to the subject(b) No interventions as a result of the test occur until after the subject’s participation in the study.