A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Safety and Efficacy of Tenapanor for the Treatment of IBS-C in Pediatric Patients 12 to 18 Years Old
A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Safety and Efficacy of Tenapanor for the Treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in Pediatric Patients 12 to Less than 18 Years Old
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Clinical Trial Information
Trial Contact: Casillas, Bridey L; Tilme, Linda
Trial Phone: 321.841.9772 ; 321.843.5278
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IRB No: 23.092.05
Protocol Abbrev: TEN-01-304
Principal Investigator: Akash Pandey, MD
Phase: Drug: Phase III
Age Group: Pediatric
Treatment: Drug: Tenapanor 50 MG Drug: Tenapanor 25 mg bid Drug: Placebo
ClinicalTrials.gov ID: NCT05643534
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Objective
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.
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Key Eligibility
≥12 and <18 years old
Patient weighs ≥18 kg at the time the patient provides written assent
Females of child-bearing potential must have negative pregnancy test at Visit 1 (serum) and Visit 2 (urine) and confirm the use of appropriate contraception (including abstinence).
Patient meets the Rome IV criteria for child/adolescent diagnosis of IBS-C
Patient is willing to discontinue any laxatives used in favor of the protocol-permitted rescue medicine (which will only be allowed after 72 hours with no bowel movement)
Patient meets the entry criteria assessed during the 2-week Screening period.
Ability of both the patient and parent/guardian/LAR to communicate with the Investigator and to comply with the requirements of the entire study, including an understanding of the assessments in the eDiary and how to use the eDiary device
Patient must provide written assent and the parent/guardian/LAR must provide written informed consent before the initiation of any study-specific procedures
