By InvitationPhase 3

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

United States150 participantsStarted 2023-02-17

Plain-language summary

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

Age range6 Years – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. ≥6 and \<18 years old at enrollment of either parent study
✓. Patient completed the parent study immediately with adequate compliance with study procedures in the opinion of the Investigator
✓. 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).
✓. Subject is ambulatory
✓. 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

✕. Patient discontinued prematurely from the parent study.
✕. Any surgery on the stomach, small intestine or colon, excluding appendectomy or cholecystectomy
✕. Pregnant or lactating women
✕. If, in the opinion of the Investigator, patient is unable or unwilling to fulfill the requirements of the protocol

Safety Measure Assessment (Adverse Event)

Timeframe: 40 weeks

Safety Measure Assessment (ECG)

Timeframe: 40 weeks

NCT IDNCT05905926

SponsorArdelyx

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2031-07