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

This is an interventional treatment trial for Irritable Bowel Syndrome With Constipation Read More

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.