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

NCT04880876 | Enrolling By Invitation Phase 3 DMC FDA Drug

• 1 other identifier: 3030-302-002
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome with Diarrhea IBSD IBS-D Irritable Bowel Syndrome Pediatric

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (7)

Open Label 6-11 years of age: Eluxadoline 50mg

EXPERIMENTAL

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

Drug: 25mg Eluxadoline

Open Label 12-17 years of age: Eluxadoline 100 mg

EXPERIMENTAL

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.

Drug: 25mg Eluxadoline; Drug: 100mg Eluxadoline

Double Blind 6-11 years of age: Eluxadoline 25mg

EXPERIMENTAL

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

Drug: 25mg Eluxadoline

Double Blind 6-11 years of age: Eluxadoline 50mg

EXPERIMENTAL

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

Drug: 25mg Eluxadoline

Double Blind 12-17 years of age: Eluxadoline 25mg

EXPERIMENTAL

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

Drug: 25mg Eluxadoline

Double Blind 12-17 years of age: Eluxadoline 50mg

EXPERIMENTAL

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

Drug: 25mg Eluxadoline

Double Blind 12-17 years of age: Eluxadoline 100mg

EXPERIMENTAL

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

Drug: 25mg Eluxadoline

Interventions

25mg Eluxadoline DRUG

Oral Tablets

Double Blind 12-17 years of age: Eluxadoline 100mg; Double Blind 12-17 years of age: Eluxadoline 25mg; Double Blind 12-17 years of age: Eluxadoline 50mg; Double Blind 6-11 years of age: Eluxadoline 25mg; Double Blind 6-11 years of age: Eluxadoline 50mg; Open Label 12-17 years of age: Eluxadoline 100 mg; Open Label 6-11 years of age: Eluxadoline 50mg

100mg Eluxadoline DRUG

Oral Tablets

Open Label 12-17 years of age: Eluxadoline 100 mg

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (6)

Kindred Medical Institute, LLC /ID# 227595

Corona, California, 92879, United States

Location

Valencia Medical & Research Center /ID# 246221

Miami, Florida, 33165, United States

Location

Florida Research Center, Inc. /ID# 227597

Miami, Florida, 33174, United States

Location

Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 227600

Stockbridge, Georgia, 30281, United States

Location

IPS Research Company /ID# 227594

Oklahoma City, Oklahoma, 73106, United States

Location

Preferred Primary Care Physicians, Inc. /ID# 227596

Pittsburgh, Pennsylvania, 15236, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

eluxadoline

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: May 11, 2021
• Study Start: August 13, 2021
• Primary Completion (Estimated): December 1, 2032
• Study Completion (Estimated): December 1, 2032
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

US (6)