Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C

Launched by ARDELYX · Jun 13, 2023

Keywords

ClinConnect Summary

This is an open-label, long-term safety study of tenapanor (also called Ibsrela) for children and teens with Irritable Bowel Syndrome with Constipation (IBS-C). The study will look mainly at safety over about 40 weeks, with participants continuing tenapanor at the same dose they had in a previous related study (either 50 mg twice daily or 25 mg twice daily, after the first week). Because this is an open-label, single-group study, everyone and the researchers know what treatment is being given and there is no comparison group.

If your child is eligible, they must be 6 to under 18 years old, have completed the prior parent study, be able to walk/participate in activities, and for females of child-bearing potential, have a negative pregnancy test and use contraception. Exclusions include not finishing the parent study, certain abdominal surgeries, pregnancy, or other reasons the investigator thinks participation isn’t right. Participants will visit about every 6 weeks for safety checks, including adverse events and a heart test (ECG), to help determine long-term safety of continuing tenapanor in children with IBS-C. The study is sponsored by Ardelyx, runs at multiple U.S. sites, and enrollment is by invitation, with overall completion expected in 2031.

Gender

ALL

Eligibility 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