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4-Week, Multi-center Dose-Ranging Study for the IBS-C in Pts. 6 to <12 Yrs

NCT06553547 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-05-12

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled dose-ranging study to assess the safety and efficacy of tenapanor for treatment of the IBS-C in pediatric patients 6 to less than 12 year old.

Conditions

  • Irritable Bowel Syndrome With Constipation (IBS-C)

Interventions

DRUG

Tenapanor

Tenapanor 5 mg/mL solution

DRUG

Placebo

Matching Placebo solution

Sponsors & Collaborators

  • Ardelyx

    lead INDUSTRY

Principal Investigators

  • Jocelyn Tabora · Ardelyx

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-07-24
Primary Completion
2026-06-30
Completion
2026-06-30
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 NCT06553547 on ClinicalTrials.gov