Clinical Trial

4-Week, Multi-center Dose-Ranging Study for the IBS-C in Pts. 6 to <12 Yrs

Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Record status
This record was last updated June 4, 2026 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
Summary
This is a randomized, double-blind, placebo-controlled dose-ranging study to assess the safety and efficacy of tenapanor for treatment of the IBS-C in pediatric patients 6 to less than 12 year old.
Protocol Amendment History 4 changes
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-06-05
notable Primary completion pushed: 2026-06 -> 2026-07 2026-06-05
minor Completion pushed: 2026-06 -> 2026-07 2026-06-05
notable Trial sites expanded: 17 -> 20 locations 2026-05-13
Trial Details
NCT Number NCT06553547
Lead Sponsor Ardelyx
Conditions Irritable Bowel Syndrome With Constipation (IBS-C)
Enrollment 72 participants
Start Date 2024-07-24
Primary Completion 2026-07 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2026-06-04