Efficacy and Safety of Plecanatide in Children 6 to <18 Years of Age With Irritable Bowel Syndrome With Constipation (IBS-C) ((IBS-C))

A Randomized, Double-blind, Placebo-Controlled, Dose Ranging, Parallel-Group Study of the Efficacy and Safety of Plecanatide in Children 6 to <18 Years of Age With Irritable Bowel Syndrome With Constipation (IBS-C)

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)

Study Overview

• Status: Recruiting
• Conditions: Irritable Bowel Syndrome With Constipation
• Intervention / Treatment: Drug: Plecanatide; Drug: Matching placebo

Detailed 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 Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Corona, California, United States, 92879
      • Recruiting
      • Synergy Research Site
  • Florida
    • Doral, Florida, United States, 33122
      • Recruiting
      • Synergy Research Site
    • Hialeah, Florida, United States, 33012
      • Recruiting
      • Synergy Research Site
    • Miami, Florida, United States, 33134
      • Recruiting
      • Synergy Research Site
    • Miami, Florida, United States, 33136
      • Recruiting
      • Synergy Research Site
    • Miami, Florida, United States, 33155
      • Recruiting
      • Synergy Research Site
    • Tampa, Florida, United States, 33607
      • Recruiting
      • Synergy Research Site
  • Louisiana
    • Crowley, Louisiana, United States, 70526
      • Recruiting
      • Synergy Research Site
  • Texas
    • Houston, Texas, United States, 77061
      • Recruiting
      • Synergy Research Site
    • San Antonio, Texas, United States, 78215
      • Recruiting
      • Synergy Research Site
  • Virginia
    • Newport News, Virginia, United States, 23606
      • Recruiting
      • Synergy Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

INCLUSION CRITERIA

A patient will be eligible for study participation if he or she meets all of the following criteria:

1. Male or female child aged 6 to < 18;
2. Meets ROME IV criteria for child/adolescent IBS-C
3. Patient's parent/guardian/LAR is able to voluntarily provide written, signed, and dated consent and patient is able to voluntarily provide assent as per IRB guidance;
4. Patient and patient's parent/guardian/LAR demonstrates an understanding, ability, and willingness to fully comply with study procedures

EXCLUSION CRITERIA

A patient will be excluded from the study if he or she meets any of the following criteria:

1. The patient has a mental age <4 years in the investigator's opinion;
2. The patient has previously been diagnosed with anorectal malformations, neurological deficits, or anatomical anomalies that would constitute a predisposition to constipation;
3. The patient is pregnant or lactating;
4. The patient's mobility or normal exercise tolerance is compromised in the investigator's opinion;
5. The patient has been screened for or participated in another Synergy study in the past;
6. The patient has a sibling that is currently participating or has participated in another Synergy study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 0.5 mg plecanatide; Plecanatide 0.5 mg Taken orally once daily for 4 weeks Group A: 6 to 11 years old	Drug: Plecanatide; Taken orally daily for 4 weeks; Other Names: Trulance
EXPERIMENTAL: 1.0 mg plecanatide; Plecanatide 1.0 mg Taken orally daily for 4 weeks Group A: 6 to 11 years old Group B: 12 to < 18 years old	Drug: Plecanatide; Taken orally daily for 4 weeks; Other Names: Trulance
EXPERIMENTAL: 2.0 mg plecanatide; Plecanatide 2.0 mg Taken orally daily for 4 weeks Group B: 12 to < 18 years old	Drug: Plecanatide; Taken orally daily for 4 weeks; Other Names: Trulance
EXPERIMENTAL: 3.0 mg plecanatide; Plecanatide 3.0 mg Taken orally daily for 4 weeks Group B: 12 to < 18 years old	Drug: Plecanatide; Taken orally daily for 4 weeks; Other Names: Trulance
PLACEBO_COMPARATOR: Matching placebo; Matching placebo Taken orally daily for 4 weeks Group A: 6 to 11 years old Group B: 12 to < 18 years old	Drug: Matching placebo; Taken orally daily for 4 weeks; Other Names: No other names

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in weekly SBM frequency over the 4 Week Treatment Period compared to placebo and across treatment groups	4 Week

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in frequency and severity of abdominal pain/discomfort	4 Week
Change from baseline in frequency of BMs and CSBMs	4 Week
Change from baseline in stool consistency (BSFS or mBSFS-C)	4 Week

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 30, 2018
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: July 12, 2018
• First Submitted That Met QC Criteria: July 12, 2018
• First Posted (ACTUAL): July 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Constipation; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Guanylyl Cyclase C Agonists; Enzyme Activators; Plecanatide
• Other Study ID Numbers: SP304202-14

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No