Clinical Trial

Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years

Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
This is a randomized, double-blind, placebo-controlled study to assess the efficacy, safety and tolerability of tenapanor (25 mg and 50 mg) in pediatric patients (≥12 and \<18 years old) with IBS-C when administered twice daily (BID) for 12 consecutive weeks.
Protocol Amendment History 3 changes
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-06-05
notable Primary completion pushed: 2026-06-01 -> 2026-09-01 2026-06-05
minor Completion pushed: 2026-06-01 -> 2026-09-01 2026-06-05
Trial Details
NCT Number NCT05643534
Lead Sponsor Ardelyx
Conditions Irritable Bowel Syndrome With Constipation (IBS-C)
Enrollment 180 participants
Start Date 2022-11-15
Primary Completion 2026-09-01 (estimated)
Study Completion 2026-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-04