Clinical Trials Logo
  1. Home
  2. Functional Constipation
  3. NCT05151328

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

Functional Constipation Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05151328
Study type Interventional
Source Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.
Contact
Status Active, not recruiting
Phase Phase 3
Start date March 18, 2022
Completion date April 1, 2024
View Details
See also
  Status Clinical Trial Phase
Completed NCT04506801 - The Effect of Probiotics on Functional Constipation in the Elderly N/A
Completed NCT04620161 - A Proof of Concept Study of Pradigastat in Patients With Functional Constipation Phase 2
Active, not recruiting NCT02361749 - Botulinum Toxin Injection Versus Anal Myectomy in Management of Idiopathic Constipation Phase 4
Completed NCT03054805 - The Effect of Probiotics on Constipation, and Intestinal Microflora in Children With Functional Constipation Phase 4
Not yet recruiting NCT01913665 - The Effect of Bifidobacterium Lactis and Inulin on Functional Constipation N/A
Completed NCT01348152 - Effect of TU-100 in Patients With Functional Constipation Phase 2
Completed NCT01622972 - Mode of Action of Moviprep Phase 4
Completed NCT01212146 - Probiotic-enriched Artichoke in Functional Constipation N/A
Completed NCT04231162 - Effect of an 8-week Bifidobacterium Lactis HN019 Supplementation on Functional Constipation N/A
Not yet recruiting NCT03639142 - Dried Plums (Prunes) vs. Polyethylene Glycol 4000 for Treatment of Functional Constipation in Children Phase 3
Recruiting NCT04918329 - Functional Digestive Disorders Observatory
Completed NCT02592200 - Effect of Lactobacillus Gasseri DSM 27123 on Functional Constipation in Healthy Women N/A
Completed NCT03707002 - Effect of scFOS on Increase in Stool Frequency in Constipated People N/A
Recruiting NCT06083311 - The Efficacy of a Probiotic for Functional Constipation (FC) N/A
Completed NCT04110145 - Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation Phase 2
Recruiting NCT06196073 - Visceral Osteopathy in Functional Constipation N/A
Completed NCT04026113 - Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC) Phase 3
Completed NCT02359396 - A Randomized, Open-label, Three-arm Study of MZRW on Tolerability, Exposure and Pharmacokinetics Phase 1
Completed NCT01847950 - Effects of scFOS on Stool Frequency in People With Functionnal Constipation N/A
Recruiting NCT01274793 - Trial for Quantity-Effect Relationship of Acupuncture With Two-ways Regulation to Treat Functional Enteropathy Phase 1