A 4-Week, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety and Efficacy of Tenapanor for the Treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in Pediatric Patients 6 to Less than 12 Years Old
A 4-Week, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety and Efficacy of Tenapanor for the Treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in Pediatric Patients 6 to Less than 12 Years Old
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Clinical Trial Information
Trial Contact: Tilme, Linda
Trial Phone: 321.843.5278
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IRB No: 24.071.05
Protocol Abbrev: TEN-01-202
Principal Investigator: Akash Pandey, MD
Phase: Drug: Phase II
Age Group: Pediatric
ClinicalTrials.gov ID: NCT06553547
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Objective
Primary:
• To assess the safety and efficacy of tenapanor when administered BID for 4 weeks in pediatric patients (≥6 and <12 years old) with IBS-C
Secondary:
• To identify appropriate dose(s) of tenapanor to allow for safe and effective use of tenapanor in pediatric patients (≥6 and <12 years old) with IBS-C
