Clinical effectiveness of two esomeprazole presentations in a pilot trial

Abstract

Introduction: This pilot studied the clinical effectiveness of two presentations of esomeprazole in patients with dyspepsia with undiagnosed causes. Methods: We conducted a pilot clinical trial of two 40 mg Esomeprazole presentations. Patients with dyspepsia of unknown cause at a gastroenterology clinic in a referral hospital were included. They received one or the other presentation daily for 28 days. Patients were initially evaluated with endoscopy and biopsy and received follow-up examinations at two and four weeks. Adverse events were recorded, and clinical symptom scales and quality of life questionnaires validated in Spanish (SODA and QoL-PEI) were used. In addition, gastric pH levels were measured continuously for 24 hours on day 14 of treatment. Serum levels of the medication administered were also measured on day 14 of treatment. A two-way repeated measures ANOVA was used to compare mean differences between the two groups. When significant differences in times were found, a Bonferroni correction was made. Results: A total of 33 patients were randomized into two groups: 16 patients in one group and 17 in the other. There were no differences in the percentages of gastric pH inhibition at day 14 of treatment (p = 0.9795). There were no differences in serum level concentrations on day 14 (p = 0.2199). No significant differences were found in severity and quality of life scales in the first two weeks of treatment. However, in the last two weeks of treatment the test product showed a larger decrease in pain (p = 0.0048) and superiority in compliance (p = 0.01) on the SODA subscale. There were no serious adverse events, and there were no statistical differences between the presentations of non-serious adverse events. Conclusions: The Test product and the Reference product showed similar effects on clinically relevant variables.