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

Phase 2

Recruiting

• Conditions: Irritable Bowel Syndrome With Constipation
• Interventions: Drug: Matching placebo; Drug: Plecanatide

• Registration Number: NCT03596905
• Lead Sponsor: Bausch Health Americas, Inc.

Brief 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)

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 Timeline

• Study Start: 2018-06-30
• Study First Submitted: 2018-07-12
• Study First Submitted QC: 2018-07-12
• Study First Posted: 2018-07-24
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Matching placebo	Matching placebo	Matching placebo Taken orally daily for 4 weeks Group A: 6 to 11 years old Group B: 12 to \< 18 years old
0.5 mg plecanatide	Plecanatide	Plecanatide 0.5 mg Taken orally once daily for 4 weeks Group A: 6 to 11 years old
1.0 mg plecanatide	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
2.0 mg plecanatide	Plecanatide	Plecanatide 2.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old
3.0 mg plecanatide	Plecanatide	Plecanatide 3.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Synergy Research Site; 🇺🇸 Newport News, Virginia, United States