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

Conditions

• Irritable Bowel Syndrome With Constipation (IBS-C)

Eligibility Criteria

Sex

ALL

Age

12 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Tenapanor 50 MG — DRUG
  Participants will receive tenapanor 50 mg BID (total of 100 mg daily)
• Tenapanor 25 mg bid — DRUG
  Participants will receive tenapanor 25 mg BID (total of 50 mg daily)
• Placebo — DRUG
  Participants will be randomized to receive matching placebo

Study Details

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.

Key Dates

Start date

Nov 15, 2022

Status verified

Jun 2026

Primary completion

Sep 1, 2026

Completion

Sep 1, 2026

Study Design

Enrollment

180 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Tenpanor 50 mg BID
  Patients will be randomized to receive 50 mg tenapanor twice daily
• Experimental: Tenpanor 25 mg BID
  Patients will be randomized to receive 25 mg tenapanor twice daily
• Placebo Comparator: Placebo Comparator
  Patients will be randomized to receive matching placebo twice daily

Primary Outcome Measure

6/12-week APS (abdominal pain and SBM) +2 response [ Time Frame: 12 weeks ]

Locations (39)

Find similar trials in Foley, AL

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