[Gastric endoscopic assessment after treatment with orally administered ketoprofen lysine salt (80 mg granular sachet). Controlled study vs placebo].
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).
Fatti
F
F
Centro per le Malattie Reumatiche, Ospedale di Mantova.
Ghirardini
M
M
Martini
A
A
de' Lorenzi
C
C
D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D004304:Dosage Forms; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005753:Gastric Mucosa / Q000187:drug effects*; D005773:Gastroscopy; D006801:Humans; D007660:Ketoprofen / Q000008:administration & dosage / Q000031:analogs & derivatives*; D008239:Lysine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D008297:Male
D000894:Anti-Inflammatory Agents, Non-Steroidal; D004304:Dosage Forms; C029946:ketoprofen lysine; D007660:Ketoprofen; D008239:Lysine
Valutazione endoscopica gastrica dopo trattamento con ketoprofene sale di lisina 80 mg granulato in bustine per uso orale. Studio controllato vs placebo.