Eluxadoline for Irritable Bowel Syndrome

Recruiting at 71 trial locations

Overseen By ABBVIE CALL CENTER

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Allergan

Disqualifiers: No gallbladder, Major GI surgery, Constipation, Inflammatory bowel disease, Celiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

95 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called eluxadoline to determine its effectiveness for children with irritable bowel syndrome with diarrhea (IBS-D), which causes frequent stomach pain and loose stools. Researchers aim to understand the safety and mechanism of this medication in children aged 6 to 11. Participants should have ongoing IBS-D symptoms, such as stomach pain and frequent diarrhea, for at least two months before joining. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that eluxadoline is usually well tolerated by individuals with irritable bowel syndrome with diarrhea (IBS-D). Studies identified constipation and nausea as the most common side effects. However, there is an increased risk of serious pancreatitis, which could lead to hospitalization or even death, particularly in certain patients. Understanding these risks is crucial before deciding to join a trial. Consulting a healthcare professional is essential to determine if this treatment is appropriate. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Eluxadoline is unique because it targets both mu- and kappa-opioid receptors while blocking the delta-opioid receptor, which is different from many standard treatments for irritable bowel syndrome (IBS) that primarily focus on either gut motility or serotonin pathways. This dual action aims to reduce bowel contractions and relieve pain without significantly slowing down the digestive system, potentially offering a balanced approach to symptom management. Researchers are excited about Eluxadoline because it could provide effective relief with fewer side effects like constipation, a common issue with other IBS medications.

What evidence suggests that eluxadoline might be an effective treatment for irritable bowel syndrome?

Research has shown that eluxadoline can help treat irritable bowel syndrome with diarrhea (IBS-D). In earlier studies, participants taking eluxadoline experienced improved stool consistency and reduced abdominal pain compared to those on a placebo. They also had fewer and less urgent bowel movements, common symptoms of IBS-D. This trial will test eluxadoline in doses of 25 mg, 50 mg, and 100 mg, alongside a placebo group. These findings suggest that eluxadoline may effectively manage IBS-D symptoms. ^{4 6 7 8 9}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for kids aged 6-17 with IBS-D, which means they have tummy pain and diarrhea but not constipation or other bowel diseases. They should be able to use an eDiary (or their parents can help) and mustn't have had certain surgeries or conditions like celiac disease. Girls who can have babies must test negative for pregnancy and agree to use reliable birth control.

Inclusion Criteria

I am between 6 and 17 years old and have my guardian's consent to participate.

I am a woman who can have children and have had negative pregnancy tests.

I am using reliable birth control methods if I am sexually active.

Exclusion Criteria

I haven't had major abdominal surgery in the last 3 months.

I have had diverticulitis in the last 3 months.

I have celiac disease or a positive test for it without a biopsy ruling it out.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive eluxadoline or placebo for 4 weeks to evaluate its therapeutic effect on IBS-D

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Eluxadoline
• Placebo

Trial Overview

The study tests Eluxadoline, a drug meant to ease IBS-D symptoms in children, against a placebo (a pill with no active drug). It also checks how the body processes the drug and its safety. Kids will randomly get either Eluxadoline or the placebo while researchers track their symptom changes.

How Is the Trial Designed?

Group I: Placebo Experimental Treatment 1 Intervention

Dose-matched placebo, oral administration, twice daily

Group II: Eluxadoline 50mg Experimental Treatment 1 Intervention

Eluxadoline 50mg, oral administration, twice daily

Group III: Eluxadoline 25mg Experimental Treatment 1 Intervention

Eluxadoline 25mg, oral administration, twice daily

Group IV: Eluxadoline 100mg Experimental Treatment 1 Intervention

Eluxadoline 100mg, oral administration, twice daily

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

Approved in United States as Viberzi for:

• Irritable Bowel Syndrome with Diarrhea (IBS-D)

Who Is Running the Clinical Trial?

Allergan

Lead Sponsor

Trials

782

Recruited

277,000+

Brent Saunders

Allergan

Chief Executive Officer since 2015

JD and MBA from Temple University

Dr. David Nicholson

Allergan

Chief Medical Officer since 2015

MD from Harvard Medical School

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

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

Eluxadoline is associated with a significant risk of pancreatitis, accounting for 16.4% of adverse event reports, with 53 cases requiring hospitalization, highlighting a serious safety concern.

Compared to other antidiarrheal medications, the incidence of pancreatitis linked to eluxadoline is markedly higher, suggesting a need for reevaluation of its risk-benefit profile, especially in light of recent fatalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of Pancreatitis Following Treatment of Irritable Bowel Syndrome With Eluxadoline. Gawron, AJ., Bielefeldt, K.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eluxadoline: A Review in Diarrhoea-Predominant Irritable Bowel Syndrome. Keating, GM.[2018]

Eluxadoline is a promising treatment for diarrhea-predominant irritable bowel syndrome (IBS-D), acting as a μ- and κ-opioid receptor agonist and δ-opioid receptor antagonist, which helps reduce diarrhea and abdominal pain without affecting the central nervous system.

Clinical trials have shown that eluxadoline effectively alleviates symptoms of IBS-D, making it a valuable option for patients suffering from this increasingly common gastrointestinal disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical potential of eluxadoline in the treatment of diarrhea-predominant irritable bowel syndrome. Sobolewska-Włodarczyk, A., Włodarczyk, M., Storr, M., et al.[2020]

Eluxadoline (Viberzi) is an effective treatment for irritable bowel syndrome with diarrhea, providing relief from symptoms in patients.

The medication works by targeting specific receptors in the gut to help regulate bowel movements and reduce diarrhea, making it a valuable option for managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eluxadoline (Viberzi): A Mu-Opioid Receptor Agonist for the Treatment Of Irritable Bowel Syndrome With Diarrhea. Maltz, F., Fidler, B.[2020]

In two phase 3 trials involving 2427 adults with irritable bowel syndrome (IBS) with diarrhea, eluxadoline significantly improved symptoms compared to placebo, with 25.1% of patients on the 100 mg dose achieving a composite response of reduced abdominal pain and improved stool consistency over 12 weeks.

Eluxadoline was generally safe, with common side effects including nausea and constipation; however, there were rare cases of pancreatitis (0.3% of patients), indicating the need for monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eluxadoline for Irritable Bowel Syndrome with Diarrhea. Lembo, AJ., Lacy, BE., Zuckerman, MJ., et al.[2022]

Eluxadoline is a first-in-class oral medication that acts as both a µ-opioid receptor agonist and a δ-opioid receptor antagonist, specifically designed to treat diarrhoea-predominant irritable bowel syndrome (IBS-D) in adults.

The drug has received approval in the US, marking a significant milestone in its development, with plans for submissions to other global regulatory authorities underway.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eluxadoline: First Global Approval. Garnock-Jones, KP.[2018]

Eluxadoline 100 mg is effective in relieving abdominal pain in irritable bowel syndrome (IBS), showing comparable efficacy to various antispasmodics based on a network meta-analysis of 42 trials involving 8,457 participants.

Despite its effectiveness, eluxadoline was associated with more reported adverse events compared to antispasmodics, suggesting that antispasmodics remain the preferred first-line treatment for IBS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eluxadoline Versus Antispasmodics in the Treatment of Irritable Bowel Syndrome: An Adjusted Indirect Treatment Comparison Meta-analysis. Qin, D., Tao, QF., Huang, SL., et al.[2022]

Eluxadoline is a mixed opioid receptor agonist and antagonist that was approved for treating diarrhea-predominant irritable bowel syndrome, showing benefits in controlling stool consistency and abdominal pain, which improves patients' quality of life.

The drug has good tolerability in most cases, but ongoing monitoring and further studies are needed to explore its use in various treatment scenarios and to assess its cost-effectiveness compared to existing therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eluxadoline in the treatment of diarrhea-predominant irritable bowel syndrome. The SEPD perspective. Vera, I., Júdez, FJ.[2018]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6738625/

Efficacy and Safety of Eluxadoline in Patients With Irritable ...

A higher percentage of patients receiving eluxadoline also achieved the secondary endpoints of improvements in stool consistency and abdominal pain compared to ...

2.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa1505180

Eluxadoline for Irritable Bowel Syndrome with Diarrhea

Patients who received eluxadoline reported a decrease in stool frequency and in urgency, which are two of the most bothersome symptoms of IBS ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31356229/

Efficacy and Safety of Eluxadoline in Patients With Irritable ...

Results: Over 12 weeks, a significantly greater proportion of eluxadoline patients achieved the primary composite responder endpoint compared to placebo (22.7% ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S001650851300499X

Eluxadoline Benefits Patients With Irritable Bowel ...

Patients receiving eluxadoline at 100 mg and 200 mg also had greater improvements in bowel movement frequency and urgency, global symptoms, quality of life, and ...

5.

frontiersin.org

frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2022.757969/full

Eluxadoline Versus Antispasmodics in the Treatment of ...

Conclusion: Our network meta-analysis showed that eluxadoline 100 mg was at least as effective as antispasmodics in relieving abdominal pain in ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/27922029/

Safety of Eluxadoline in Patients with Irritable Bowel ...

Eluxadoline was well tolerated in Phase 2 and 3 trials, with constipation and nausea the most common AEs. Consistent with the known adverse effects of ...

7.

fda.gov

fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-about-increased-risk-serious-pancreatitis-irritable-bowel-drug

Irritable bowel drug Viberzi (eluxadoline)

An FDA review found these patients have an increased risk of developing serious pancreatitis that could result in hospitalization or death.

8.

viberzihcp.com

viberzihcp.com/safety-profile

Safety Profile - Viberzi® (eluxadoline) CIV

Adverse events (AEs) were reported in >2% of patients treated with VIBERZI at either dose and at an incidence greater than in patients treated with placebo.

9.

mayoclinic.org

mayoclinic.org/drugs-supplements/eluxadoline-oral-route/description/drg-20146792

Eluxadoline (oral route) - Side effects & dosage

Eluxadoline is used to treat adults with irritable bowel syndrome with diarrhea (IBS-D). ... Safety and efficacy have not been established.