Gastric endoscopic assessment after treatment with orally administered ketoprofen lysine salt (80 mg granular sachet) . Controlled study vs placebo
Fatti, F.; Ghirardini, M.; Martini, A.; de' Lorenzi, C.
Minerva Medica 85(10): 531-535
1994
ISSN/ISBN: 0026-4806 PMID: 7800195 Document Number: 425348
In this study, a new oral granular formulation of ketoprofen lysine salt, a non steroidal antiinflammatory drug (NSAID) derived from propionic acid, and placebo, were compared for their local effect on the gastric mucosa of healthy, human volunteers. The study was carried out with a double-blind, randomized, parallel-group, design. 10 healthy volunteers were administered one sachet containing 80 mg of ketoprofen lysine salt and 10 volunteers with placebo. The subjects were gastroscoped at baseline and following 10 days drug administration; tolerability was assessed by analysis of the hematology and biochemistry laboratory results, the adverse reaction reports and by the Investigator's and subject's global assessment at the final visit. No symptoms of gastric intolerance were referred in both groups. No statistically significant differences were found between treatments in laboratory results and in final post-treatment tolerability evaluation (Mann-Whitney's test U, Phi and Cramer tests).