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Enrolling by Invitation

NCT Number: NCT04880876

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

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kindred Medical Institute, LLC /ID# 227595, Corona, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

25mg Eluxadoline

Drug

Oral Tablets

100mg Eluxadoline

Drug

Oral Tablets

Primary outcomes

  1. Percentage of Participants with Adverse Events

    Time frame: 52 weeks

  2. Percentage of Participants with Clinically Significant Laboratory Values (clinical chemistry, complete blood count, urinalysis) as assessed by the Investigator

    Time frame: 52 weeks

  3. Percentage of Participants with Clinically Significant ECGs as assessed by the Investigator

    Time frame: 52 weeks

  4. Percentage of Participants with Clinically Significant vital sign measurements as assessed by the Investigator

    Time frame: 52 weeks

  5. Percentage of Participants with any new Physical examination abnormality or worsening of change from baseline

    Time frame: 52 weeks

  6. Percentage of Participants with any new neurological abnormality post baseline or worsening of change from baseline

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2032
Study completion
2032
First posted
May 11, 2021
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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