Overview

Tenapanor for the Treatment of Pediatric Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Status:
Enrolling by invitation

Trial end date:
2031-10-01

Target enrollment:
0

Participant gender:
All

Summary

Open-label long-term safety study of tenapanor in pediatric patients with IBS-C.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Ardelyx

Criteria

Inclusion Criteria:

1. ≥6 and <18 years old at enrollment of either parent study

2. Patient completed the parent study immediately with adequate compliance with study
procedures in the opinion of the Investigator

3. Females of child-bearing potential must have negative pregnancy test at the last visit
of the parent study and confirm the use of appropriate contraception (including
abstinence).

4. Subject is ambulatory

5. Written informed consent by parent/guardian/ Legally Authorized Representative (LAR)
and a willingness of both subject and parent/guardian/LAR to participate in the study
as it is described

Exclusion Criteria:

1. Patient discontinued prematurely from the parent study.

2. Any surgery on the stomach, small intestine or colon, excluding appendectomy or
cholecystectomy

3. Pregnant or lactating women

4. If, in the opinion of the Investigator, patient is unable or unwilling to fulfill the
requirements of the protocol