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Enrolling by invitation NCT04880876

A Study Evaluating Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)

Phase III Interventional Irritable Bowel Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 25mg Eluxadoline, 100mg Eluxadoline.
Who it may be relevant to
Registry conditions: Irritable Bowel Syndrome. Basic parameters: 6 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3, Long-term Safety Study of Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)

Overview

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.

Interventions

  • Drug 25mg Eluxadoline
    Oral Tablets
  • Drug 100mg Eluxadoline
    Oral Tablets

Primary outcome measures

  • Percentage of Participants with Adverse Events [Time frame: 52 weeks]
  • Percentage of Participants with Clinically Significant Laboratory Values (clinical chemistry, complete blood count, urinalysis) as assessed by the Investigator [Time frame: 52 weeks]
  • Percentage of Participants with Clinically Significant ECGs as assessed by the Investigator [Time frame: 52 weeks]
  • Percentage of Participants with Clinically Significant vital sign measurements as assessed by the Investigator [Time frame: 52 weeks]
  • Percentage of Participants with any new Physical examination abnormality or worsening of change from baseline [Time frame: 52 weeks]
  • Percentage of Participants with any new neurological abnormality post baseline or worsening of change from baseline [Time frame: 52 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 6 centers
  • Kindred Medical Institute, LLC /ID# 227595 — Corona
  • Valencia Medical & Research Center /ID# 246221 — Miami
  • Florida Research Center, Inc. /ID# 227597 — Miami
  • Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 227600 — Stockbridge
  • IPS Research Company /ID# 227594 — Oklahoma City
  • Preferred Primary Care Physicians, Inc. /ID# 227596 — Pittsburgh

Identifiers

NCT: NCT04880876 · 3030-302-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗