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

Irritable Bowel Syndrome With Constipation Clinical Trial

— (IBS-C)  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03596905
• Other study ID #: SP304202-14
• Status: Recruiting
• Phase: Phase 2
• Start date: June 30, 2018
• Est. completion date: December 2023

Study information

• Verified date: February 2023
• Source: Bausch Health Americas, Inc.
• Contact: Susan Harris
• Phone: 908-300-9220
• Email: susan.harris[@]bauschhealth.com
• Is FDA regulated: No
• Study type: Interventional

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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constipation
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome With Constipation
• Syndrome

Intervention

Drug:
• Plecanatide
Taken orally daily for 4 weeks
• Matching placebo
Taken orally daily for 4 weeks

Locations

Country	Name	City	State
United States	Synergy Research Site	Corona	California
United States	Synergy Research Site	Crowley	Louisiana
United States	Synergy Research Site	Doral	Florida
United States	Synergy Research Site	Hialeah	Florida
United States	Synergy Research Site	Houston	Texas
United States	Synergy Research Site	Miami	Florida
United States	Synergy Research Site	Miami	Florida
United States	Synergy Research Site	Miami	Florida
United States	Synergy Research Site	Newport News	Virginia
United States	Synergy Research Site	San Antonio	Texas
United States	Synergy Research Site	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in weekly SBM frequency over the 4 Week Treatment Period compared to placebo and across treatment groups		4 Week
Secondary	Change from baseline in frequency and severity of abdominal pain/discomfort		4 Week
Secondary	Change from baseline in frequency of BMs and CSBMs		4 Week
Secondary	Change from baseline in stool consistency (BSFS or mBSFS-C)		4 Week