drugset / Trial / NCT05643534

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

NCT05643534

Phase 3 Active not recruiting 180 enrolled Ardelyx
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2022-11-15
Primary completion
2026-09-01
Completion
2026-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Tenapanor Small molecule 25 mg
Subject Tenapanor Small molecule 50 mg