A Randomized, Placebo-Controlled, Multicenter Study of The Safety and Efficacy of A New Polyethylene Glycol Laxative

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OBJECTIVE:This study was designed to determine the efficacy and safety of a new laxative, Braintree polyethylene glycol (PEG) laxative (Miralax, Braintree 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 ≤2 stools during a 7-day qualification period. Braintree PEG laxative 17 g or dextrose placebo 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 passage, cramps, and flatus. CBC, blood chemistries and urinalysis were performed before and after the treatment period.RESULTS:There were 151 randomized subjects, 131 female and 20 male. An increase in bowel movement frequency was observed with the PEG laxative as compared to placebo (p < 0.001), with the greatest difference in efficacy in wk 2 of treatment (p < 0.001). By wk 2 of treatment, on average, placebo subjects had 2.7 bowel movements/wk and PEG-treated study subjects had 4.5 movements/wk (p < 0.01), or more than one bowel movement every 2 days. Investigator (p < 0.005) and patient (p < 0.001) subjective assessment of perception 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 PEG laxative is safe and effective in the short term for the treatment of constipation.

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