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Enrolling by invitationPhase 3

Long-term safety of eluxadoline in children and teens with diarrhea-type irritable bowel syndrome

Tests eluxadoline's long-term safety in young people with diarrhea-predominant irritable bowel syndrome.

Key facts

Who runs it
AbbVie
Where
Corona, Miami, Oklahoma City, Pittsburgh, and Stockbridge, United StatesSee the 6 sites
Trial code
Registry title
A Study Evaluating Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)
Status
Enrolling by invitation
Phase
Phase 3
People taking part
124 people, planned
Started
13 Aug 2021
Expected to end
Dec 2032
Type of study
Interventional, 7 groups
Treatments tested
  • 25mg Eluxadoline
  • 100mg Eluxadoline
Record updated
17 July 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teens with irritable bowel syndrome with diarrhea (IBS-D). They must have finished treatment in an earlier eluxadoline study (3030-202-002 or 3030-303-002).

Age
6 to 17 years
Sex
Boys and girls
Disease stage
Irritable bowel syndrome with diarrhea (IBS-D)
Earlier treatment
Must have completed the study treatment in the earlier lead-in study.

Main reasons for not taking part

  • Allergy to opioids
  • Pregnant or breastfeeding, or planning to be during the study
  • No gallbladder, or blocked bile ducts or sphincter of Oddi problems
  • History of pancreatitis or pancreas disease, or chronic or severe constipation or bowel blockage
  • Kidney problems, unstable liver, metabolic or blood conditions, or regular or heavy alcohol use

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • Male or female participants must be 6 to 17 years of age (inclusive)
  • Participants must have completed study intervention in their lead-in study

Who cannot take part

  • Participant has known allergies or hypersensitivity to opioids
  • 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
  • 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
  • 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)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 6 and 17 years old?

Where in United States

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

About the trial

What the trial wants to find out

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.

The 7 groups in the trial

  • Open Label 6-11 years of age: Eluxadoline 50mgTreatment being tested

    Eluxadoline two 25mg tablets, oral administration, twice daily with food. Take at approximately the same time each day.

    Treatment: 25mg Eluxadoline

  • Open Label 12-17 years of age: Eluxadoline 100 mgTreatment being tested

    Eluxadoline one 100mg tablet, oral administration, twice daily with food. May use 25mg tablets to administer 100mg dose. Take at approximately the same time each day.

    Treatment: 25mg Eluxadoline and 100mg Eluxadoline

  • Double Blind 6-11 years of age: Eluxadoline 25mgTreatment being tested

    Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID

    Treatment: 25mg Eluxadoline

  • Double Blind 6-11 years of age: Eluxadoline 50mgTreatment being tested

    Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID

    Treatment: 25mg Eluxadoline

  • Double Blind 12-17 years of age: Eluxadoline 25mgTreatment being tested

    Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID

    Treatment: 25mg Eluxadoline

  • Double Blind 12-17 years of age: Eluxadoline 50mgTreatment being tested

    Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID

    Treatment: 25mg Eluxadoline

  • Double Blind 12-17 years of age: Eluxadoline 100mgTreatment being tested

    Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID

    Treatment: 25mg Eluxadoline

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase 3, Long-term Safety Study of Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)
Plain-language title
Long-term safety of eluxadoline in children and teens with diarrhea-type irritable bowel syndromeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT04880876, who can take part
Record updated
17 July 2025