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NCT05643534 · ClinicalTrials.gov registry record · Phase 3
Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years
A Phase 3 study of Irritable Bowel Syndrome With Constipation (IBS-C), sponsored by Ardelyx.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 180
- Enrollment target
- 20
- Study locations
NCT05643534: Recruiting Phase 3 study of Irritable Bowel Syndrome With Constipation (IBS-C), sponsored by Ardelyx.
NCT05643534 is a Phase 3 study of Irritable Bowel Syndrome With Constipation (IBS-C) that is actively recruiting participants, run by Ardelyx. The registered enrollment target is 180 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05643534, a Phase 3 study of Irritable Bowel Syndrome With Constipation (IBS-C), is actively recruiting participants, sponsored by Ardelyx.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 180 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
6/12-week APS (abdominal pain and SBM (spontaneous bowel movement)) +2 response, defined as achieving the weekly APS +2 response criteria (i.e., achieving both weekly SBM +2 response and weekly abdominal pain response during the same week) for ≥6 out of the 12 weeks of the RTP. * The weekly SBM +2 response is defined as having an increase of ≥2 from baseline in the average weekly SBM frequency for a given week * The weekly abdominal pain response is defined as having ≥30% reduction from baselin
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Tenapanor 50 MG
- DRUG Tenapanor 25 mg bid
Study Locations (20)
Florida
- Prohealth Research Center - Doral
- I.H.S. Health, LLC - Kissimmee
- Waterway Research & Associates Corp - Miami
- Valencia Medical and Research Center - Miami
- Orlando Health, Inc.- APH Center for Digestive Health and Nutrition - Orlando
- Florida Pharmaceutical Research and Associates, Inc. - South Miami
Alabama
- G & L Research, LLC - Foley
Arizona
- Eclipse Clinical Research - Tucson
California
- Advanced Research Center, Inc. - Anaheim
Connecticut
- Connecticut Children's Medical Center - Hartford
Georgia
- Clinical Research Institute - Stockbridge
Illinois
- OSF Saint Francis Medical Center - Peoria
Indiana
- Riley Children's Health IUH - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2022-11-15 |
| Est. Completion | 2026-06-01 |
| Phase | Phase 3 |
What NCT05643534 shows while recruiting
NCT05643534 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Irritable Bowel Syndrome With Constipation (IBS-C) appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05643534 names 20 study sites across 15 states, led by Florida, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT05643534 about?
NCT05643534 is a clinical study titled "Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years". 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.
What is the current status of trial NCT05643534?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 180 participants. The study started on 2022-11-15. Estimated completion is 2026-06-01.
What conditions does trial NCT05643534 study?
This clinical trial studies the following conditions: Irritable Bowel Syndrome With Constipation (IBS-C).
What interventions are being tested in trial NCT05643534?
The interventions under investigation include: Placebo (DRUG), Tenapanor 50 MG (DRUG), Tenapanor 25 mg bid (DRUG).
Who is sponsoring clinical trial NCT05643534?
This trial is sponsored by Ardelyx, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05643534 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Irritable Bowel Syndrome With Constipation (IBS-C)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05643534's enrollment target sits among peer trials
180 1423rd of 2000 higher than 564 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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