124 Participants Needed

Eluxadoline for Pediatric IBS-D

Recruiting at 9 trial locations
CT
AC
Overseen ByABBVIE CALL CENTER
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial will check the safety of a medication called Eluxadoline for children with IBS-D who have already taken part in earlier studies. The medication helps to reduce diarrhea and stomach pain by slowing down bowel movements. Eluxadoline is a new drug approved for managing diarrhea predominant irritable bowel syndrome (IBS-D).

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

How is the drug eluxadoline different from other treatments for pediatric IBS-D?

Eluxadoline is unique because it works on three different opioid receptors in the gut, helping to manage diarrhea-predominant irritable bowel syndrome (IBS-D) by reducing symptoms like abdominal pain and stool consistency. Unlike some other treatments, it is taken orally and acts locally in the gastrointestinal tract, with a generally well-tolerated safety profile.12345

Who Is on the Research Team?

AI

ALLERGAN INC.

Principal Investigator

Allergan

Are You a Good Fit for This Trial?

This trial is for kids aged 6-17 with IBS-D who've finished a previous Phase 2 or Phase 3 study. They can't join if they're pregnant, nursing, plan to be pregnant, have opioid allergies, no gallbladder, biliary or pancreatic issues, severe liver/kidney/blood conditions, alcohol abuse history or intend to drink during the study.

Inclusion Criteria

Participants must have completed study intervention in their lead-in study
I am between 6 and 17 years old.

Exclusion Criteria

I have had pancreatitis or problems with my pancreas structure.
I have a blockage in my bile ducts or issues with the sphincter of Oddi.
You have an ongoing health issue or abnormal results from medical tests that may affect your safety or ability to participate in the study.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral Eluxadoline, either open-label or double-blind, based on previous study completion

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Eluxadoline
Trial Overview The trial tests long-term safety of Eluxadoline (100mg and 25mg doses) in children with IBS-D. It's for those who completed earlier phases of the research and now need further evaluation over an extended period.
How Is the Trial Designed?
7Treatment groups
Experimental Treatment
Group I: Open Label 6-11 years of age: Eluxadoline 50mgExperimental Treatment1 Intervention
Group II: Open Label 12-17 years of age: Eluxadoline 100 mgExperimental Treatment2 Interventions
Group III: Double Blind 6-11 years of age: Eluxadoline 50mgExperimental Treatment1 Intervention
Group IV: Double Blind 6-11 years of age: Eluxadoline 25mgExperimental Treatment1 Intervention
Group V: Double Blind 12-17 years of age: Eluxadoline 50mgExperimental Treatment1 Intervention
Group VI: Double Blind 12-17 years of age: Eluxadoline 25mgExperimental Treatment1 Intervention
Group VII: Double Blind 12-17 years of age: Eluxadoline 100mgExperimental Treatment1 Intervention

Eluxadoline is already approved in United States for the following indications:

🇺🇸
Approved in United States as Viberzi for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials
1,079
Recruited
535,000+
Founded
2013
Headquarters
North Chicago, USA
Known For
Immunology treatments
Top Products
Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael profile image

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Allergan

Lead Sponsor

Trials
782
Recruited
277,000+
Brent Saunders profile image

Brent Saunders

Allergan

Chief Executive Officer since 2015

JD and MBA from Temple University

Dr. David Nicholson profile image

Dr. David Nicholson

Allergan

Chief Medical Officer since 2015

MD from Harvard Medical School

Published Research Related to This Trial

In phase 3 trials involving patients with diarrhoea-predominant irritable bowel syndrome (IBS-D), eluxadoline significantly improved abdominal pain and stool consistency compared to placebo after 12 and 26 weeks of treatment.
Eluxadoline was generally well tolerated, with constipation being the most common side effect, but no serious complications were reported, making it a safe treatment option for IBS-D.
Eluxadoline: A Review in Diarrhoea-Predominant Irritable Bowel Syndrome.Keating, GM.[2018]

Citations

Eluxadoline in the treatment of diarrhea-predominant irritable bowel syndrome. [2018]
Eluxadoline: A Review in Diarrhoea-Predominant Irritable Bowel Syndrome. [2018]
Spotlight on eluxadoline for the treatment of patients with irritable bowel syndrome with diarrhea. [2022]
Efficacy and Safety of Eluxadoline in Patients With Irritable Bowel Syndrome With Diarrhea Who Report Inadequate Symptom Control With Loperamide: RELIEF Phase 4 Study. [2020]
Eluxadoline Demonstrates a Lack of Abuse Potential in Phase 2 and 3 Studies of Patients With Irritable Bowel Syndrome With Diarrhea. [2018]
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