Eluxadoline for Pediatric IBS-D
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the long-term safety of Eluxadoline, a medication for children and teens with IBS-D (Irritable Bowel Syndrome with Diarrhea). Participants will receive Eluxadoline in varying doses, either openly or in a double-blind setup, meaning some will not know if they are receiving the actual medication or a placebo. It suits those aged 6 to 17 who have completed earlier study phases and regularly experience IBS-D symptoms. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that eluxadoline is generally well tolerated by adults with irritable bowel syndrome with diarrhea (IBS-D). Studies have found that common side effects include nausea and constipation, but these are usually mild. Importantly, serious side effects rarely occur. Although eluxadoline is approved for adults, its safety and effectiveness in children remain under investigation. This trial aims to gather more information on how well children handle the medication over time.12345
Why do researchers think this study treatment might be promising for IBS-D?
Eluxadoline is unique because it offers a targeted approach to treating pediatric IBS-D (Irritable Bowel Syndrome with Diarrhea) by acting directly on the gut's opioid receptors to reduce diarrhea and abdominal pain. Unlike traditional treatments for IBS-D, such as loperamide or antispasmodics, which often focus on just slowing gut movement, eluxadoline combines both mu-opioid receptor agonism and delta-opioid receptor antagonism to provide a dual action that helps manage symptoms more effectively. Researchers are excited about eluxadoline because it represents a novel mechanism that could offer improved symptom relief with potentially fewer side effects, making it a promising option for young patients.
What evidence suggests that Eluxadoline might be an effective treatment for pediatric IBS-D?
Research has shown that Eluxadoline helps reduce symptoms of IBS with diarrhea in adults. Studies have found that it firms stools and reduces stomach pain. Many patients reported better control over bowel movements, fewer urgent trips to the bathroom, and an improved overall quality of life. This trial will evaluate Eluxadoline's effectiveness in children with IBS-D, testing various dosages and administration methods for participants aged 6-17. These findings suggest Eluxadoline might also help treat IBS-D in children.26789
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 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral Eluxadoline, either open-label or double-blind, based on previous study completion
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
7
Treatment groups
Experimental Treatment
Eluxadoline two 25mg tablets, oral administration, twice daily with food. Take at approximately the same time each day.
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.
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
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
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
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
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
Eluxadoline is already approved in United States for the following indications:
- Irritable Bowel Syndrome with Diarrhea (IBS-D)
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
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
Allergan
Lead Sponsor
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
Published Research Related to This Trial
Citations
Eluxadoline for Irritable Bowel Syndrome with Diarrhea
Eluxadoline is a new therapeutic agent that reduced symptoms of IBS with diarrhea in men and women, with sustained efficacy over 6 months.
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 ...
NCT03339128 | Study to Explore the Therapeutic Effect of ...
The primary objectives of this study are to explore the therapeutic effect of eluxadoline in treating irritable bowel syndrome with diarrhea (IBS-D) in ...
Study to Explore the Therapeutic Effect of Eluxadoline in ...
The primary objectives of this study are to explore the therapeutic effect of eluxadoline in treating IBS-D in pediatric patients 12-17 years of age, to ...
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 ...
Eluxadoline in irritable bowel syndrome with diarrhea
Safety and tolerability data, pooled from both phase II and III studies, suggest that eluxadoline is generally well tolerated with the most ...
highlights of prescribing information - accessdata.fda.gov
treatment of irritable bowel syndrome with diarrhea (IBS-D). (1) ... It is not known if VIBERZI is safe and effective in children. People 65 years old ...
NCT04880876 | A Study Evaluating Oral Eluxadoline ...
This study will assess the long-term safety of oral Eluxadoline administered to pediatric participants with IBS-D who have completed study intervention in ...
Eluxadoline (oral route) - Side effects & dosage
Eluxadoline is used to treat adults with irritable bowel syndrome with diarrhea (IBS-D). This medicine is available only with your doctor's prescription.
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