NCT05151328

Efficacy and Safety of Plecanatide Comparing With Placebo in the Treatment of Functional Constipation

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 648 (actual)
• Sponsor: Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Functional Constipation

Interventions

Type	Name	Description
DRUG	Plecanatide	Plecanatide or Placebo; Route of Plecanatide/placebo administration: tablet; dosage: 3mg, dosage form oral; Frequency of administration: QD

Timeline

• Start date: 2022-03-18
• Primary completion: 2023-10-12
• Completion: 2023-10-26
• First posted: 2021-12-09
• Last updated: 2024-07-11

Locations

1 site across 1 country: China