Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years
← catalyst calendarNCT05643534 · readout in 13 d
Sponsored by Ardelyx (industry) · ARDX — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
180actual
Sites
39
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-11-15 | actual | When the study began enrolling |
| Primary completion | 2026-09-01 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-09-01 | estimated | The whole study's end, after follow-up |
| First posted | 2022-12-08 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-04 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Irritable Bowel Syndrome With Constipation (IBS-C)
Interventions
- Drug: Tenapanor 50 MG
- Drug: Tenapanor 25 mg bid
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OF6/12-week APS (abdominal pain and SBM) +2 response
measured 12 weeks
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