Clinical Trials in the USA / NCT05905926
Enrolling by invitation
Phase 3
Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C
NCT05905926 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Irritable Bowel Syndrome With Constipation (IBS-C)
Investigational drug(s) / intervention(s)
Tenapanor: Eligible patients from the parent study will continue tenapanor at the same dose assigned in the parent study. Doses can be titrated to either 50 mg BID or 25 mg BID
Study summary
Open-label long-term safety study of tenapanor in pediatric patients with IBS-C.
Eligibility
Inclusion Criteria:
1. ≥6 and \<18 years old at enrollment of either parent study
2. Patient completed the parent study immediately with adequate compliance with study procedures in the opinion of the Investigator
3. Females of child-bearing potential must have negative pregnancy test at the last visit of the parent study and confirm the use of appropriate contraception (including abstinence).
4. Subject is ambulatory
5. Written informed consent by parent/guardian/ Legally Authorized Representative (LAR) and a willingness of both subject and parent/guardian/LAR to participate in the study as it is described
Exclusion Criteria:
1. Patient discontinued prematurely from the parent study.
2. Any surgery on the stomach, small intestine or colon, excluding appendectomy or cholecystectomy
3. Pregnant or lactating women
4. If, in the opinion of the Investigator, patient is unable or unwilling to fulfill the requirements of the protocol
Primary outcome measure(s)
- Safety Measure Assessment (Adverse Event) — 40 weeks
Incidence of AEs, SAEs and drug related adverse events - Safety Measure Assessment (ECG) — 40 weeks
Descriptive summaries of ECG parameters (heart rate, PR-interval, QRS-duration, QT-interval, QTc-interval, and RR-interval)
Trial sites (27)
| Facility | City | Region | Status |
|---|---|---|---|
| G & L Research, LLC | Foley | Alabama | |
| Advanced Research Center, Inc. | Anaheim | California | |
| Prohealth Research Center | Doral | Florida | |
| I.H.S. Health, LLC | Kissimmee | Florida | |
| Valencia Medical and Research Center | Miami | Florida | |
| Orlando Health, Inc.- APH Center for Digestive Health and Nutrition | Orlando | Florida | |
| Florida Pharmaceutical Research and Associates, Inc. | South Miami | Florida | |
| OSF Saint Francis Medical Center | Peoria | Illinois | |
| Riley Children's Health | Indianapolis | Indiana | |
| Maine Health | Portland | Maine | |
| Mankato Clinic/ Javara Research Ltd | Mankato | Minnesota | |
| Boys Town National Research Hospital | Boys Town | Nebraska | |
| SUNY Downstate Medical Center | Brooklyn | New York | |
| Advantage Clinical Trials | The Bronx | New York | |
| Atrium Health | Charlotte | North Carolina | |
| Duke University School of Medicine | Durham | North Carolina | |
| Wilmington Health | Wilmington | North Carolina | |
| Frontier Clinical Research, LLC | Scottdale | Pennsylvania | |
| Frontier Clinical Research, LLC | Smithfield | Pennsylvania | |
| Prisma Health Children's Hospital | Greenville | South Carolina | |
| Advance Clinical Trial PLLC | Abilene | Texas | |
| Maspons Pediatric Gastro | El Paso | Texas | |
| Texas Digestive Specialists | Harlingen | Texas | |
| AIM Trials, LLC | Plano | Texas | |
| Sun Research Institute | San Antonio | Texas | |
| Pioneer Research Solutions Inc | Sugar Land | Texas | |
| Frontier Clinical Research | Kingwood | West Virginia |
More Ardelyx trials in the USA
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05905926 on ClinicalTrials.gov ↗ ← All trials in the USA