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Synergy Pharmaceuticals
SGYP today announced the start of
the first of two planned phase 3 clinical trials to confirm the safety
and efficacy of plecanatide, its lead GC-C agonist and once-daily oral
treatment, in adult patients with chronic idiopathic constipation (CIC).
The pivotal phase 3 trial is a randomized, double-blind, clinical trial
to compare a 12-week, dose-ranging regimen of plecanatide (3.0 and
6.0mg) against placebo in adult patients with CIC. The study will be
conducted at approximately 180 sites in the United States and Canada and
will enroll approximately 1350 patients with CIC. The primary endpoint
of the study is the proportion of patients who are overall responders
for the 12-week treatment period.
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