QUALITY-OF-LIFE RESULTS OF DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF MESALAMINE IN PATIENTS WITH CROHNS-DISEASE

Seven quality-of-life parameters were assessed in a trial of mesalamine in Crohn's disease. The results with regard to efficacy and safety have been previously published. A total of 310 patients were enrolled in this double-blind, parallel trial and randomized to receive placebo, or 1, 2, or 4 g/day of mesalamine in controlled-release capsules for 16 weeks. Results revealed that mesalamine at the dose of 4 g/day resulted in significant (P < 0.03) improvements from baseline in all quality-of-life parameters. A significant (P < 0.02) linear trend between increasing doses of mesalamine and increasing response was also noted. The 1- and 2-g/day doses of mesalamine also resulted in an improvement in quality of life, however, with the exception of 2 g/day of mesalamine on the hobby and recreational activities parameter, these changes were not significantly different from placebo.