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

Evaluating Tenapanor for IBS-C in Kids 12-17.

Recruiting
12-17 years
All
Phase 3
  • Simplified description (AI rewritten)
  • Technical description (Original)
Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years This study is testing a medicine called tenapanor in young people aged 12 to 18 who have a condition called IBS-C, which stands for Irritable Bowel Syndrome with Constipation. It is a "double-blind" study, meaning neither the doctors nor the patients know who is getting the actual medicine or a placebo, which is a pill that looks like the medicine but has no active ingredients. The study lasts 12 weeks, and patients will take the medicine twice a day. They will also use an electronic diary to record how they feel each day. This helps doctors see how the medicine is working.
  • The study lasts for 12 weeks, with visits every two to four weeks for check-ups.
  • Participants will use an electronic diary to report daily symptoms.
  • Eligible patients will receive either a low or high dose of tenapanor or a placebo.
Note: Eligibility requirements include being 12-18 years old, weighing at least 18 kg, and meeting specific health criteria. Participants must also stop any other laxatives they may be using in favor of a study-provided medicine.
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Study details
    Irritable Bowel Syndrome With Constipation (IBS-C)

NCT05643534

Ardelyx

1 April 2025

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