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NCT06553547 · ClinicalTrials.gov registry record · Phase 2
4-Week, Multi-center Dose-Ranging Study for the IBS-C in Pts. 6 to <12 Yrs
A Phase 2 study of Irritable Bowel Syndrome With Constipation (IBS-C), sponsored by Ardelyx.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
- 17
- Study locations
NCT06553547 is a Phase 2 study of Irritable Bowel Syndrome With Constipation (IBS-C) that is actively recruiting participants, run by Ardelyx. The registered enrollment target is 72 participants. The trial reports 17 study locations across 11 states.
The verdict
NCT06553547, a Phase 2 study of Irritable Bowel Syndrome With Constipation (IBS-C), is actively recruiting participants, sponsored by Ardelyx.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
- 17
- Study locations
Study Summary
This is a randomized, double-blind, placebo-controlled dose-ranging study to assess the safety and efficacy of tenapanor for treatment of the IBS-C in pediatric patients 6 to less than 12 year old.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Tenapanor
Study Locations (17)
Florida
- 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
Texas
- Maspons Pediatric Gastro - El Paso
- Proactive El Paso, LLC - El Paso
- Texas Digestive Specialists - Harlingen
- Pioneer Research Solutions Inc - Sugar Land
Arkansas
- Applied Research Center of Arkansas - Little Rock
Connecticut
- Connecticut Children's Medical Center - Hartford
Illinois
- OSF Saint Francis Medical Center - Peoria
Minnesota
- Mankato Clinic Children's Health Center - Mankato
Nebraska
- Boys Town National Research Hospital - Boys Town
Ohio
- One Perkins Square - Akron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2024-07-24 |
| Est. Completion | 2026-06 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06553547
The ClinicalTrials.gov registry entry for NCT06553547 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 72 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 2 interventions - of which Placebo is the first listed.
NCT06553547 reports 17 study locations spanning 11 distinct geographic areas - top geographies include Florida, Texas, Arkansas.
Frequently Asked Questions
What is clinical trial NCT06553547 about?
NCT06553547 is a clinical study titled "4-Week, Multi-center Dose-Ranging Study for the IBS-C in Pts. 6 to <12 Yrs". This is a randomized, double-blind, placebo-controlled dose-ranging study to assess the safety and efficacy of tenapanor for treatment of the IBS-C in pediatric patients 6 to less than 12 year old.
What is the current status of trial NCT06553547?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2024-07-24. Estimated completion is 2026-06.
What conditions does trial NCT06553547 study?
This clinical trial studies the following conditions: Irritable Bowel Syndrome With Constipation (IBS-C).
What interventions are being tested in trial NCT06553547?
The interventions under investigation include: Placebo (DRUG), Tenapanor (DRUG).
Who is sponsoring clinical trial NCT06553547?
This trial is sponsored by Ardelyx, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06553547 being conducted?
This trial has 17 study locations across Arkansas, Connecticut, Florida, Illinois, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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