Clinical Trials in the USA / NCT04880876
Enrolling by invitation
Phase 3
A Study Evaluating Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)
NCT04880876 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Irritable Bowel Syndrome
Investigational drug(s) / intervention(s)
25mg Eluxadoline100mg Eluxadoline
25mg Eluxadoline: Oral Tablets
100mg Eluxadoline: Oral Tablets
Study summary
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.
Eligibility
Inclusion Criteria:
Inclusion Criteria:
* Male or female participants must be 6 to 17 years of age (inclusive)
* Participants must have completed study intervention in their lead-in study
Exclusion Criteria:
* Participant has an unresolved AE or a clinically significant finding on a physical examination, vital sign assessment, or neurological assessment along with an ECG or clinical laboratory tests (if results are available by the time of enrollment) that; in the opinion of the investigator, could represent a safety concern or a condition that would be exclusionary, could prevent the participant from performing any protocol assessments, or could confound study assessments.
* Participant has known allergies or hypersensitivity to opioids
* Female participants who are currently pregnant or nursing, or plan to become pregnant or nurse during the clinical study.
* Participant has no gallbladder, (ie, agenesis of the gallbladder or cholecystectomy).
* Participant has known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction
* Participant has a history of pancreatitis; structural diseases of the pancreas, known or suspected pancreatic duct obstruction
* Participant has a history of chronic or severe constipation, or sequelae from constipation, or known or suspected mechanical GI obstruction or pseudo obstruction
* Participant has renal impairment or an unstable hepatic, metabolic, or hematologic condition.
* Participant is a current regular alcohol drinker and/or binge drinker\*, and/or has a history of alcoholism, alcohol abuse (eg, binge-drinking\*), or alcohol addiction, and/or intends to consume alcohol during the study
Primary outcome measure(s)
- Percentage of Participants with Adverse Events — 52 weeks
- Percentage of Participants with Clinically Significant Laboratory Values (clinical chemistry, complete blood count, urinalysis) as assessed by the Investigator — 52 weeks
- Percentage of Participants with Clinically Significant ECGs as assessed by the Investigator — 52 weeks
- Percentage of Participants with Clinically Significant vital sign measurements as assessed by the Investigator — 52 weeks
- Percentage of Participants with any new Physical examination abnormality or worsening of change from baseline — 52 weeks
- Percentage of Participants with any new neurological abnormality post baseline or worsening of change from baseline — 52 weeks
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| Kindred Medical Institute, LLC /ID# 227595 | Corona | California | |
| Valencia Medical & Research Center /ID# 246221 | Miami | Florida | |
| Florida Research Center, Inc. /ID# 227597 | Miami | Florida | |
| Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 227600 | Stockbridge | Georgia | |
| IPS Research Company /ID# 227594 | Oklahoma City | Oklahoma | |
| Preferred Primary Care Physicians, Inc. /ID# 227596 | Pittsburgh | Pennsylvania |
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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 NCT04880876 on ClinicalTrials.gov ↗ ← All trials in the USA