Clinical Evaluation of the Anorexic Activity and Safety of 42-548 in Children

Abstract

A double-blind study comparing the safety and efficacy of 42-548, a new, synthetic tricyclic appetite suppressant, with a placebo was started with 116 obese adolescent patients. All patients received a fixed daily dose of one tablet, one hour before the noon meal, for 12 weeks. A reduced caloric intake was prescribed initially and the patients were instructed to stay on this diet. 42-548 produced an average weight loss of 18.9 lb. at the end of the study, and the placebo a loss of 11.8 lb., a statistically significant difference. The medication was relatively well tolerated.