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

Conditions

• Irritable Bowel Syndrome With Constipation (IBS-C)

Eligibility Criteria

Sex

ALL

Age

6 Years - 18 Years

Healthy Volunteers

Not accepted

Interventions

• Tenapanor — DRUG
  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

Study Details

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

Key Dates

Start date

Feb 17, 2023

Status verified

Jun 2026

Primary completion

Jul 31, 2031

Completion

Oct 31, 2031

Study Design

Enrollment

150 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Experimental: 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 Measure

Safety Measure Assessment (Adverse Event) [ Time Frame: 40 weeks ]

Locations (27)

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