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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
Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.·Phase 3·ClinicalTrials.gov·drugRecruiting
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Study focus
Disease/Condition
Functional Constipation
Drug/Device/Intervention
Plecanatide
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.
Location
Wuhan, China
Timeline & enrollment
Phase
Phase 3
Start date
Mar 18, 2022
End date
Apr 01, 2024
Enrollment
640 participants
Primary outcome

Number of Durable Overall CSBM Responders, Mean Replacement Approach

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.

ICD-10 classifications
ConstipationOther functional intestinal disordersFunctional intestinal disorder, unspecifiedOther specified functional intestinal disordersOther laxatives
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05151328
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05151328 through Pure Global AI's free database. This Phase 3 trial is sponsored by Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. and is currently Recruiting. The study focuses on Functional Constipation. Target enrollment is 640 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.