What side effects are associated with this type of intervention?

Common treatments for Irritable Bowel Syndrome with Diarrhea (IBS-D) include Eluxadoline, Alosetron, and Rifaximin. Eluxadoline can cause constipation, nausea, and abdominal pain. Alosetron is associated with constipation and, in rare cases, ischemic colitis. Rifaximin may lead to nausea and elevated liver enzymes. While these treatments are effective, they require careful monitoring for these potential side effects.

What prior FDA approvals exist?

Eluxadoline, a mixed mu-opioid receptor agonist, delta-opioid receptor antagonist, and kappa-opioid receptor agonist, has been approved by the FDA for the treatment of Irritable Bowel Syndrome with Diarrhea (IBS-D). Another FDA-approved drug for IBS-D is Alosetron hydrochloride (Lotronex), a 5-HT3 antagonist, which has shown efficacy in reducing symptoms such as urgency and abdominal pain, particularly in females. Both drugs aim to manage the symptoms of IBS-D by targeting different pathways involved in gastrointestinal motility and pain.

What other types of research exist?

For IBS-D, promising alternatives to Eluxadoline include Rifaximin, a non-absorbable antibiotic that targets gut bacteria, and Alosetron, a selective serotonin 5-HT3 antagonist. For IBS-C, Linaclotide and Plecanatide, both guanylate cyclase-C agonists, are promising options. These medications have shown efficacy in clinical trials and offer different mechanisms of action compared to Eluxadoline.

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Mu-opioid Receptor Agonist

Eluxadoline for Pediatric IBS-D

Phase 3

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female participants must be 6 to 17 years of age (inclusive)

Be younger than 18 years old

Must not have

Participant has a history of pancreatitis; structural diseases of the pancreas, known or suspected pancreatic duct obstruction

Participant has known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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).

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Eluxadoline may cause side effects similar to opioids like nausea, constipation and abdominal pain. There could also be reactions due to hypersensitivity in some kids.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 6 and 17 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had pancreatitis or problems with my pancreas structure.

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I have a blockage in my bile ducts or issues with the sphincter of Oddi.

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I have kidney problems or unstable liver, blood, or metabolic conditions.

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I do not have a gallbladder.

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I am not pregnant or nursing, nor do I plan to be during the study.

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I have a history of severe or chronic constipation or related complications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

7Treatment groups

Experimental Treatment

Group I: Open Label 6-11 years of age: Eluxadoline 50mgExperimental Treatment1 Intervention

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

Group II: Open Label 12-17 years of age: Eluxadoline 100 mgExperimental Treatment2 Interventions

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.

Group III: Double Blind 6-11 years of age: Eluxadoline 50mgExperimental Treatment1 Intervention

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

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

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Eluxadoline works by modulating opioid receptors in the gut, which helps to reduce bowel contractions, alleviate pain, and improve stool consistency in patients with IBS-D. Specifically, it acts as a mu-opioid receptor agonist to decrease bowel motility, a delta-opioid receptor antagonist to reduce pain, and a kappa-opioid receptor agonist to further modulate gut function. This multi-receptor approach is significant for IBS patients as it targets multiple symptoms simultaneously, offering a comprehensive treatment option. Other treatments like loperamide work by slowing down gut movement to reduce diarrhea, while bile acid sequestrants bind bile acids to prevent them from causing diarrhea. Antispasmodics help by relaxing the muscles in the gut to reduce pain and cramping. These mechanisms are crucial as they directly address the disruptive symptoms of IBS, improving patients' quality of life.

Impact of patient and disease characteristics on the efficacy and safety of eluxadoline for IBS-D: a subgroup analysis of phase III trials.Eluxadoline for the treatment of diarrhoea-predominant irritable bowel syndrome.New therapeutic options for IBS: the role of the first in class mixed µ- opioid receptor agonist and δ-opioid receptor antagonist (mudelta) eluxadoline.