A randomized phase III clinical trial of plecanatide, a uroguanylin analog, in patients with chronic idiopathic constipation
The American Journal of Gastroenterology
March 08, 2017
Miner Jr PB, et al.
This trial was performed to examine the efficacy and safety of plecanatide, a guanylate cyclase–C (GC–C) agonist, in the treatment of chronic idiopathic constipation (CIC). Researchers concluded that plecanatide significantly improved constipation and its related symptoms with a low rate of adverse events. These results suggest that plecanatide will be a useful treatment option in the management of CIC.
This phase III, multicenter, double–blind, placebo–controlled study randomized 1,394 patients with CIC.
Patients received either plecanatide (3 or 6 mg) or placebo, orally, once daily, for 12 weeks.
The primary efficacy endpoint was the percentage of patients who were complete spontaneous bowel movement (CSBM) responders over the 12–week treatment period.
Patients were instructed to record their daily bowel movements, stool consistency scores, and abdominal symptoms in a diary.
Treatment–emergent adverse events (AEs) were collected.
Each dose of plecanatide resulted in a significantly greater percentage of durable overall CSBM responders (21.0%, 3 mg; 19.5%, 6 mg) vs placebo (10.2%; P<0.001 for both).
Plecanatide (3 and 6 mg) significantly increased mean weekly CSBM frequency from baseline (increase of 2.5 and 2.2/week, respectively) vs placebo (1.2/week; P<0.001 for both).
Mean weekly spontaneous bowel movement frequency (increase of 3.2 and 3.1/week, respectively) vs placebo (1.3/week; P<0.001, for both) over the 12–week treatment period.
Both plecanatide doses significantly improved all secondary and additional efficacy endpoints.
The most common AE, diarrhea, occurred in 1.3% (placebo), 5.9% (3 mg) and 5.7% (6 mg) of patients.
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