A comparative placebo-controlled endoscopic evaluation of damaging effects of indomethacin farnesil on the gastric and duodenal mucosa

Abstract

To evaluate the gastroduodenal mucosal damaging action and its mechanisms of an inactive form of indomethacin farnesil (IND·F) (as a prodrug of indomethacin), compared with placebo, a double blind controlled randomized study was carried out in 19 healthy normal volunteers.
Indomethacin farnesil (IND·F) 400 mg or IND·F placebo twice daily were administered for 2 weeks with an endoscopic assessment on baseline and 14 days after treatment.
Utilizing a previously established criterion of a score 1 or less as a clinically significant degree of protection to the gastroduodenal mucosa, we found that the success rate for IND·F was 25% (2/8), compared to 0% (0/9) for placebo. However, no significant difference was found between IND· F treatment group and placebo administered group. The enhancement of gastric acid secretion and decrease in mucosal blood flow by indomethacin were not observed in both groups.
These findings suggest that IND·F has a low ulcerogenic potency to reduce mucosal damages.