A randomized, placebo-controlled, multicenter study of the safety and efficacy of a new polyethylene glycol laxative

OBJECTIVE: This study was designed to determine the efficacy and safety of a new laxative, Braintree polyethylene glycol (PEG) laxative (Miralax, Brai ntree Laboratories, Braintree, MA). METHODS: This investigation was designed as a placebo-controlled, blinded, randomized, multicenter parallel trial. Study subjects were constipated but otherwise healthy outpatients who had less than or equal to 2 stools durin g a 7-day qualification period. Braintree PEG laxative 17 g or dextrose pla cebo p.o. in 8 oz of water for a 14-day treatment period. A diary recorded each bowel movement and subjective symptoms of stool consistency, ease of p assage, cramps, and flatus. CBC, blood chemistries and urinalysis were perf ormed before and after the treatment period. RESULTS: There were 151 randomized subjects, 131 female and 20 male. An inc rease in bowel movement frequency was observed with the PEC laxative as com pared to placebo (p < 0.001), with the greatest difference in efficacy in w k 2 of treatment (p < 0.001). By wk 2 of treatment, on average, placebo sub jects had 2.7 bowel movements/wk and PEG-treated study subjects had 4.5 mov ements/wk (p < 0.01), or more than one bowel movement every 2 days, investi gator (p < 0.005) and patient (p < 0.001) subjective assessment of percepti on of treatment effectiveness, and patient evaluations of stool consistency and passage showed significant improvement in the active treatment group ( p < 0.001). There were no significant differences in laboratory changes or adverse experiences recorded between groups. CONCLUSION: Braintree PEC laxative is safe and effective in the short term for the treatment of constipation. (C) 2000 by Am. Coll. of Gastroenterolog y.