A Study Evaluating Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)
← catalyst calendarNCT04880876 · readout ≤ 2,326 d
Sponsored by AbbVie (industry) · ABBV — their whole pipeline →.
Phase
Phase 3
Status
Enrolling by invitation
Study type
Interventional
Design
Non randomized · Quadruple · Treatment
Enrollment
124estimated
Sites
6
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 | 2021-08-13 | actual | When the study began enrolling |
| Primary completion | Dec 2032 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2032 | estimated | The whole study's end, after follow-up |
| First posted | 2021-05-11 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-07-17 | 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
Interventions
- Drug: 25mg Eluxadoline
- Drug: 100mg Eluxadoline
Primary outcomes
what the primary-completion date above is the date OFPercentage of Participants with Adverse Events
measured 52 weeks
Percentage of Participants with Clinically Significant Laboratory Values (clinical chemistry, complete blood count, urinalysis) as assessed by the Investigator
measured 52 weeks
Percentage of Participants with Clinically Significant ECGs as assessed by the Investigator
measured 52 weeks
Percentage of Participants with Clinically Significant vital sign measurements as assessed by the Investigator
measured 52 weeks
Percentage of Participants with any new Physical examination abnormality or worsening of change from baseline
measured 52 weeks
Percentage of Participants with any new neurological abnormality post baseline or worsening of change from baseline
measured 52 weeks
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