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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tenapanor | Small molecule | 25 mg | — |
| Subject | Tenapanor | Small molecule | 50 mg | — |