drugset / Trial / NCT06553547

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

NCT06553547

Phase 2 Active not recruiting 72 enrolled Ardelyx
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2024-07-24
Primary completion
2026-07
Completion
2026-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Tenapanor Small molecule 2 mg
Subject Tenapanor Small molecule 5 mg
Subject Tenapanor Small molecule 10 mg
Subject Tenapanor Small molecule 15 mg
Subject Tenapanor Small molecule 20 mg
Subject Tenapanor Small molecule 25 mg