NCT05905926

Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C

An Open-Label Long-Term Safety Study of Tenapanor for the Treatment of Irritable Bowel Syndrome With Constipation (IBS-C) in Pediatric Patients 6 to Less Than 18 Years Old

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Ardelyx · Industry
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

Open-label long-term safety study of tenapanor in pediatric patients with IBS-C.

Detailed description

Open-label long-term safety study of tenapanor in pediatric patients with IBS-C. Eligible patients who complete the parent study will have an option to enroll in this study. Patients from the parent study will continue tenapanor at the same dose assigned in the parent study which can be titrated to either 50 mg BID or 25 mg BID per guidance in protocol after a patient's first week on the assigned dose. Patients will also return for study visits approximately every 6 weeks for safety assessments.

Conditions

• Irritable Bowel Syndrome With Constipation (IBS-C)

Interventions

Type	Name	Description
DRUG	Tenapanor	Eligible patients from the parent study will continue tenapanor at the same dose assigned in the parent study. Doses can be titrated to either 50 mg BID or 25 mg BID

Timeline

• Start date: 2023-02-17
• Primary completion: 2031-07-01
• Completion: 2031-10-01
• First posted: 2023-06-15
• Last updated: 2026-01-12

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated drug study