Efficacy and Safety of Plecanatide Comparing With Placebo in the Treatment of Functional Constipation - Trial NCT05151328
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.
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Study Focus
Sponsor & Location
Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.
Timeline & Enrollment
Phase 3
Mar 18, 2022
Apr 01, 2024
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
Data Source
ClinicalTrials.gov
NCT05151328
Non-Device Trial