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

Phase 3

• Conditions: Irritable Bowel Syndrome With Constipation (IBS-C)
• Interventions: Drug: Tenapanor

• Registration Number: NCT05905926
• Lead Sponsor: Ardelyx

Brief 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.

Study Timeline

• Study Start: 2023-02-17
• Study First Submitted: 2023-03-07
• Study First Submitted QC: 2023-06-13
• Study First Posted: 2023-06-15
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-04
• Last Update Posted: 2025-06-10
• Primary Completion: 2031-07
• Study Completion: 2031-10

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. ≥6 and <18 years old at enrollment of either parent study
2. Patient completed the parent study immediately with adequate compliance with study procedures in the opinion of the Investigator
3. Females of child-bearing potential must have negative pregnancy test at the last visit of the parent study and confirm the use of appropriate contraception (including abstinence).
4. Subject is ambulatory
5. Written informed consent by parent/guardian/ Legally Authorized Representative (LAR) and a willingness of both subject and parent/guardian/LAR to participate in the study as it is described

Exclusion Criteria

1. Patient discontinued prematurely from the parent study.
2. Any surgery on the stomach, small intestine or colon, excluding appendectomy or cholecystectomy
3. Pregnant or lactating women
4. If, in the opinion of the Investigator, patient is unable or unwilling to fulfill the requirements of the protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tenapanor	Tenapanor	Eligible 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 Investigator guidance after a patient's first week on the assigned dose.

Primary Outcome Measures

Name	Time	Method
Safety Measure Assessment (Adverse Event)	40 weeks	Incidence of AEs, SAEs and drug related adverse events
Safety Measure Assessment (ECG)	40 weeks	Descriptive summaries of ECG parameters (heart rate, PR-interval, QRS-duration, QT-interval, QTc-interval, and RR-interval)

Trial Locations

Locations (19)

OSF Saint Francis Medical Center; 🇺🇸 Peoria, Illinois, United States

Maspons Pediatric Gastro; 🇺🇸 El Paso, Texas, United States

G & L Research, LLC; 🇺🇸 Foley, Alabama, United States

Advanced Research Center, Inc.; 🇺🇸 Anaheim, California, United States

Prohealth Research Center; 🇺🇸 Doral, Florida, United States

I.H.S. Health, LLC; 🇺🇸 Kissimmee, Florida, United States

Valencia Medical and Research Center; 🇺🇸 Miami, Florida, United States

Florida Pharmaceutical Research and Associates, Inc.; 🇺🇸 South Miami, Florida, United States

Boys Town National Research Hospital; 🇺🇸 Boys Town, Nebraska, United States

Advantage Clinical Trials; 🇺🇸 Bronx, New York, United States

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