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

NCT05905926 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-05-12

No results posted yet for this study

Summary

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

Conditions

  • Irritable Bowel Syndrome With Constipation (IBS-C)

Interventions

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

Sponsors & Collaborators

  • Ardelyx

    lead INDUSTRY

Principal Investigators

  • Jocelyn Tabora · Ardelyx

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-17
Primary Completion
2031-07-31
Completion
2031-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05905926 on ClinicalTrials.gov