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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Synergy Pharmaceuticals Inc.
• Treatments: Plecanatide

Criteria

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.