drugset / Trial / NCT07382167

A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults

NCT07382167

Phase 3 Recruiting 692 enrolled Ardelyx
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a 26-week, multi-center, randomized, double-blind, placebo-controlled study with a 4-week treatment-free Safety Follow-up period to assess the safety and efficacy of tenapanor (5 mg, 25mg, and 50 mg) in adult patients with Chronic Idiopathic Constipation (CIC) when administered twice daily for 26 consecutive weeks.

Timeline

Start
2026-01-13
Primary completion
2027-02-26
Completion
2027-06-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Tenapanor Small molecule 5 mg
Subject Tenapanor Small molecule 25 mg
Subject Tenapanor Small molecule 50 mg

Indications