Efficacy and Safety of Plecanatide Comparing With Placebo in the Treatment of Functional Constipation
Status:
Not yet recruiting
Trial end date:
2024-04-01
Target enrollment:
Participant gender:
Summary
This is a multi-center, randomized, double-blind, Placebo-controlled Phase III clinical study
to evaluate the efficacy and safety of Plecanatide in the treatment of Functional
Constipation in Chinese patients for up to 12 weeks.
Patients will enter a Screening period which must undergo a 2-week Pre-Treatment assessment,
they will complete daily assessments of electronic dairy to demonstrate the eligibility.
Eligible subjects will be randomized into Plecanatide 3 mg group or Placebo group at Visit 1
at the ratio of 1:1 and take an oral dose of study treatment continuously for 12 weeks. For 2
weeks after complete dosing patients will continue to complete daily electronic dairy.
Patients will then return to the clinical site for efficacy and safety assessment as part of
an End of Study visit. The planned duration of participation in this study will be 154 days
and up to 164 days with all windows considered.
Phase:
Phase 3
Details
Lead Sponsor:
Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.