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
Ardelyx
Summary
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.
Description
This study consists of 2-week screening period followed by 12 week randomized treatment period (RTP) and a 2-week treatment-free Follow-Up period (only for patients who will not enter the 40-week Long Term Safety Extension Study \[TEN-01-306\]). At the beginning of the 2-week Screening period, patients who provide written assent will be fully assessed for eligibility into the study and will be asked to self-report daily information about the status of their IBS symptoms via an electronic diary (eDiary) device. Patient compliance with the eDiary will be monitored actively by the site staff and…
Eligibility
- Age range
- 12–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * ≥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 durin…
Interventions
- DrugTenapanor 50 MG
Participants will receive tenapanor 50 mg BID (total of 100 mg daily)
- DrugTenapanor 25 mg bid
Participants will receive tenapanor 25 mg BID (total of 50 mg daily)
- DrugPlacebo
Participants will be randomized to receive matching placebo
Locations (41)
- G & L Research, LLCFoley, Alabama
- Eclipse Clinical ResearchTucson, Arizona
- Advanced Research Center, Inc.Anaheim, California
- Connecticut Children's Medical CenterHartford, Connecticut
- Prohealth Research CenterDoral, Florida
- I.H.S. Health, LLCKissimmee, Florida