A prospective, single-arm, open-label, multicenter study to determine the safety and effectiveness of a fixed-dose combination of camylofin dihydrochloride and paracetamol in Indian children with acute colicky abdominal pain

Abstract

Background: The aim of this prospective, single-arm, open-label, multicenter study was to determine the safety and effectiveness of a fixed dose combination of paracetamol and the antispasmodic camylofin dihydrochloride in Indian children with acute colicky abdominal pain.Methods: A total of 197 children with acute colicky abdominal pain were enrolled to receive 2 teaspoons (10 mL) of the syrup thrice daily orally for 5 days per local label. Primary objective was to assess safety as incidence of adverse events (AEs) and change in the severity and frequency of AEs from baseline to end of treatment (EOT). Secondary objectives were effectiveness as evaluated by change in mean (standard deviation [SD]) pain intensity (based on the 100-mm visual analog scale [VAS]) and mean change in the frequency of daily pain episodes from baseline to EOT.Results: In all, 182 (92.4%) patients completed the study. Twenty AEs were reported in 17 patients (8.7%). All AEs were treatment-emergent and of non-serious type. Common AEs included anemia, vomiting, and constipation. At EOT, mean pain intensity significantly (p<0.0001) reduced to 3.3 (8.50) with a mean change of -61.5 (19.56) from baseline. Percentage change in mean intensity of pain from baseline to EOT visit was 94.9%. At EOT, the frequency of daily pain intensity significantly (p<0.0001) reduced to 1.7 (1.01) with a mean change of -3.5 (2.14) from baseline.Conclusions: A fixed-dose combination of camylofin dihydrochloride and paracetamol was effective and well tolerated and had a good safety profile in Indian children with acute colicky abdominal pain.