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Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years

NCT05643534 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-01-12

No results posted yet for this study

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.

Conditions

  • Irritable Bowel Syndrome With Constipation (IBS-C)

Interventions

DRUG

Tenapanor 50 MG

Participants will receive tenapanor 50 mg BID (total of 100 mg daily)

DRUG

Tenapanor 25 mg bid

Participants will receive tenapanor 25 mg BID (total of 50 mg daily)

DRUG

Placebo

Participants will be randomized to receive matching placebo

Sponsors & Collaborators

  • Ardelyx

    lead INDUSTRY

Principal Investigators

  • Susan Edelstein, PhD · Ardelyx

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-15
Primary Completion
2026-06-01
Completion
2026-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT05643534 on ClinicalTrials.gov