Clinical Trials Logo

Clinical Trial Summary

This study of the efficacy and safety of Plecanatide in children 6 to <18 Years of Age with Irritable Bowel Syndrome with Constipation (IBS-C)


Clinical Trial Description

The purpose of this study is to evaluate the safety, efficacy and pharmacokinetic (PK) parameters of plecanatide of once daily oral 4 dose levels of plecanatide (0.5, 1.0, 2.0, or 3.0 mg) for 4 weeks as treatment in children 6 to <18 years of age with IBS-C. The study will include a 28-day Screening/Baseline Period, a 4 week treatment period, and a 2-week post-treatment follow-up period. Patients/caregivers will visit the clinic 4 times during the study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03596905
Study type Interventional
Source Bausch Health Americas, Inc.
Contact Susan Harris
Phone 908-300-9220
Email susan.harris@bauschhealth.com
Status Recruiting
Phase Phase 2
Start date June 30, 2018
Completion date December 2023

See also
  Status Clinical Trial Phase
Completed NCT00730171 - An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation Phase 3
Completed NCT00215566 - A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of DDP733 for IBS-c Phase 2
Completed NCT00765999 - An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation Phase 3
Completed NCT02559206 - Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C) Phase 2
Recruiting NCT05646186 - Personalized Dietary Intervention Based on Microbiome Analysis vs FODMAP Diet for Irritable Bowel Syndrome 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
Recruiting NCT05519683 - Home Transcutaneous Electrical Acustimulation (TEA) Phase 2/Phase 3
Active, not recruiting NCT04166058 - Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C Phase 3
Completed NCT05164861 - Safety and Efficacy of Non-alcoholic Beverage Based on Kombucha in Patients With Constipations N/A
Completed NCT04968652 - IBS-C Questionnaire Study
Completed NCT02590432 - An Open-Label, Long-term Study to Assess the Immunogenicity of LINZESS® (Linaclotide) Administered Orally to Adult Participants With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation Phase 4
Terminated NCT02559817 - A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation Phase 2
Recruiting NCT05796388 - A Study of Virtual Reality and Linaclotide for IBS-C N/A
Completed NCT00380250 - Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation Phase 3
Completed NCT04647045 - An Evaluation of Cultured Milk Drink on Immune Status of Patients With Irritable Bowel Syndrome: Constipation Predominant N/A
Completed NCT03054506 - The Effect of CSP01 on Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation N/A
Recruiting NCT04214470 - A Non-Interventional Pilot Study to Explore the Role of Gut Flora in IBS
Not yet recruiting NCT06219707 - Electro-acupuncture for Irritable Bowel Syndrome With Constipation N/A
Completed NCT04132804 - Effect of Tai Chi as Treatment for IBS-C N/A
Completed NCT00938717 - Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C) Phase 3