Randomized clinical trial: efficacy and safety of plecanatide in the treatment of chronic idiopathic constipation.

ABSTRACT:

Background

Plecanatide, with the exception of a single amino acid replacement, is identical to human uroguanylin and is approved in the United States for adults with chronic idiopathic constipation (CIC). This double-blind, placebo-controlled, phase III study evaluated the efficacy and safety of plecanatide versus placebo in CIC.

Methods

Adults meeting modified Rome III CIC criteria were randomized to plecanatide 3 mg (n = 443), 6 mg (n = 449), or placebo (n = 445). Patients recorded bowel movement (BM) characteristics [including spontaneous BMs (SBMs) and complete SBMs (CSBMs)] and rated CIC symptoms in daily electronic diaries. The primary endpoint was the percentage of durable overall CSBM responders (weekly responders for ⩾9 of 12 treatment we

SUBMITTER: DeMicco M 

PROVIDER: S-EPMC5673020 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature