Background & Aims. The efficacy and safety of polyethylene glycol 3350 for chronic idiopathic constipation have been demonstrated in randomized controlled trials. A new US Food and Drug Administration-recommended primary efficacy endpoint for evaluating chronic idiopathic constipation prompted our reevaluation of previously reported clinical data with polyethylene glycol 3350. Methods. This multicenter, double-blind, placebo-controlled, parallel-group trial included adults with chronic idiopathic constipation randomized to polyethylene glycol 3350 17 g (n = 204) or placebo (n = 100) once daily for 24 weeks. Post hoc analyses were performed using the US Food and Drug Administration endpoint (≥3 complete spontaneous bowel movements/week and an increase of ≥1 complete spontaneous bowel movement/week from baseline for ≥9/12 weeks, including 3 of the last 4 weeks) along with additional efficacy and safety outcomes. Results. The proportion of patients meeting the new endpoint was significantly higher with polyethylene glycol 3350 vs placebo (42% vs 13%; P
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