Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years
Public ClinicalTrials.gov record NCT05643534. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05643534
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 180 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 12 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 15, 2022 (Actual)
- Primary completion
- Aug 20, 2026 (Actual)
- Completion
- Aug 20, 2026 (Actual)
- Last update posted
- Sep 22, 2026
2022 – 2026
United States locations
- U.S. sites
- 39
- U.S. states
- 21
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| G & L Research, LLC | Foley | Alabama | 36535 | — |
| Eclipse Clinical Research | Tucson | Arizona | 85745 | — |
| Applied Research Center of Arkansas | Little Rock | Arkansas | 72205 | — |
| Advanced Research Center, Inc. | Anaheim | California | 92805 | — |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | — |
| Prohealth Research Center | Doral | Florida | 33166 | — |
| I.H.S. Health, LLC | Kissimmee | Florida | 34741 | — |
| Waterway Research & Associates Corp | Miami | Florida | 33155 | — |
| Valencia Medical and Research Center | Miami | Florida | 33165 | — |
| Orlando Health, Inc.- APH Center for Digestive Health and Nutrition | Orlando | Florida | 32806 | — |
| Florida Pharmaceutical Research and Associates, Inc. | South Miami | Florida | 33143 | — |
| Clinical Research Institute | Stockbridge | Georgia | 30281 | — |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | — |
| Riley Children's Health IUH | Indianapolis | Indiana | 46202 | — |
| Maine Health | Portland | Maine | 04102 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| Mankato Clinic/ Javara Research Ltd | Mankato | Minnesota | 56001 | — |
| Boys Town National Research Hospital | Boys Town | Nebraska | 68010 | — |
| Med Clinical Research Partners, LLC | Irvington | New Jersey | 07111 | — |
| University of New Mexico Health Sciences Center | Albuquerque | New Mexico | 87131 | — |
| SUNY Downstate Medical Center | Brooklyn | New York | 11203 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| Advantage Clinical Trials | The Bronx | New York | 10467 | — |
| Atrium Health | Charlotte | North Carolina | 28203 | — |
| Duke University School of Medicine | Durham | North Carolina | 27705 | — |
| Wilmington Health | Wilmington | North Carolina | 28401 | — |
| Frontier Clinical Research, LLC | Scottdale | Pennsylvania | 15683 | — |
| Frontier Clinical Research, LLC | Smithfield | Pennsylvania | 15478 | — |
| Prisma Health Children's Hospital | Greenville | South Carolina | 29615 | — |
| Advance Clinical Trial PLLC | Abilene | Texas | 79606 | — |
| Maspons Pediatric Gastro | El Paso | Texas | 79902 | — |
| Proactive El Paso, LLC | El Paso | Texas | 79902 | — |
| Texas Digestive Specialists | Harlingen | Texas | 78550 | — |
| AIM Trials, LLC | Plano | Texas | 75093 | — |
| Sun Research Institute | San Antonio | Texas | 78215 | — |
| Pioneer Research Solutions Inc | Sugar Land | Texas | 77479 | — |
| ClinPoint Trials | Waxahachie | Texas | 75165 | — |
| University Physicians and Surgeons, Inc. | Huntington | West Virginia | 25701 | — |
| Frontier Clinical Research | Kingwood | West Virginia | 26537 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05643534, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 22, 2026 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05643534 live on ClinicalTrials.gov.