Eluxadoline for Irritable Bowel Syndrome

Recruiting at73 trial locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Allergan

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

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a medication to help manage IBS-D symptoms in children. The goal is to see how well it works, how the body processes it, and if it is safe for kids. The study focuses on children because they need effective treatments for IBS-D. The medication is taken orally and is designed to treat diarrhoea-predominant irritable bowel syndrome.

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.

What data supports the effectiveness of the drug Eluxadoline for treating irritable bowel syndrome with diarrhea?

Research shows that Eluxadoline is effective in improving abdominal pain and stool consistency in patients with diarrhea-predominant irritable bowel syndrome. In clinical trials, more patients taking Eluxadoline experienced relief compared to those taking a placebo, and it also improved other symptoms like bloating and urgency. ^{1 2 3 4 5}

Is Eluxadoline safe for humans?

Eluxadoline is generally well tolerated, but some people may experience constipation, and there is a risk of pancreatitis (inflammation of the pancreas) and sphincter of Oddi spasm (a muscle spasm affecting bile and pancreatic juice flow). These side effects are uncommon, but it's important to discuss them with your doctor. ^{1 2 3 4 6}

How does the drug Eluxadoline differ from other treatments for irritable bowel syndrome with diarrhea?

Eluxadoline is unique because it works by targeting specific receptors in the gut, acting as a mu-opioid receptor agonist and a delta-opioid receptor antagonist, which helps reduce diarrhea and abdominal pain without affecting the brain. This makes it different from other treatments that may not have this dual action or may affect the central nervous system. ^{1 2 6 7 8}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Eluxadoline (Mu-opioid Receptor Agonist)
• Placebo (Drug)

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.

Participant Groups

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

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

Findings from Research

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 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 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]

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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. New Zealand pubmed.ncbi.nlm.nih.gov

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

3. Spain pubmed.ncbi.nlm.nih.gov

Eluxadoline in the treatment of diarrhea-predominant irritable bowel syndrome. The SEPD perspective. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Risk of Pancreatitis Following Treatment of Irritable Bowel Syndrome With Eluxadoline. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Eluxadoline for Irritable Bowel Syndrome with Diarrhea. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Eluxadoline: First Global Approval. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Eluxadoline Versus Antispasmodics in the Treatment of Irritable Bowel Syndrome: An Adjusted Indirect Treatment Comparison Meta-analysis. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Clinical potential of eluxadoline in the treatment of diarrhea-predominant irritable bowel syndrome. [2020]