This study will assess the long-term safety of oral Eluxadoline administered to pediatric participants with IBS-D who have completed study intervention in the Phase 2 study 3030-202-002 or the Phase 3 study 3030-303-002.
Age range
6 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Percentage of Participants with Adverse Events
Timeframe: 52 weeks
Percentage of Participants with Clinically Significant Laboratory Values (clinical chemistry, complete blood count, urinalysis) as assessed by the Investigator
Timeframe: 52 weeks
Percentage of Participants with Clinically Significant ECGs as assessed by the Investigator
Timeframe: 52 weeks
Percentage of Participants with Clinically Significant vital sign measurements as assessed by the Investigator
Timeframe: 52 weeks
Percentage of Participants with any new Physical examination abnormality or worsening of change from baseline
Timeframe: 52 weeks
Percentage of Participants with any new neurological abnormality post baseline or worsening of change from baseline
Timeframe: 52 weeks