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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 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. The trial reports 20 study locations across 15 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05643534
The ClinicalTrials.gov registry entry for NCT05643534 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ardelyx, which has 25 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.
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Related
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