An Open-Label, Multicenter Post Marketing Study to Assess the Symptomatic Efficacy and Safety of Troxipide [TroxipTM] in the Management of Acid Peptic Disorders in Indian Patients

Abstract

Aims: A post marketing study to assess the symptomatic efficacy and safety of Troxipide (TROXIPTM) 100mg in the management of acid peptic disorders (APDs) in Indian population. Study Design: An observational, prospective, uncontrolled, open-label, multicenter post marketing study. Place and Duration of Study: Patients were enrolled from 62 centers across 11 states of India, between October 2010 and March 2012. Methodology: Out of 1500 APD patients, 1486 (850 men, 636 women; age range 16-85 years) were prescribed Troxipide 100mg tablet orally thrice daily. The efficacy and safety assessments were performed on day 14 and day 28 after beginning the treatment and recorded in the case report forms. The efficacy of Troxipide was estimated based on the changes from the baseline in the symptom score on a 100 point visual analogue scale (VAS) for individual symptoms. Safety was assessed by adverse events reported with usage of Troxipide on day 14 and day 28 after start of the treatment. Results: Troxipide monotherapy (n=1427) significantly reduced the mean VAS score from baseline for all major symptoms, viz. nausea, vomiting, belching, heart burn, epigastric pain, acid regurgitation, abdominal bloating & loss of appetite at the end of the study. The global mean VAS score (a sum of individual symptom VAS score) of these patients decreased from 134.26 ± 75.31 to 21.88 ± 39.52 at the end of the study (P < .001). All the patients who were previously treated but uncontrolled, with acid inhibitors like proton pump inhibitors (PPIs), histamine 2 receptor antagonists (H2RAs) etc. had a significant reduction in the VAS score from 164.38 ± 64.54 to 35.56 ± 54.24 on day 28 (P<.001). Troxipide was well tolerated with overall incidence of adverse events being 1.05% (n=15) and all the events were resolved without any sequel. Conclusion: The present study demonstrates that Troxipide symptomatically controls APDs like gastritis, dyspepsia, gastro-esophageal reflux disease (GERD) and ulcers with good tolerability.