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Mu-opioid Receptor Agonist
Eluxadoline for Pediatric IBS-D
Phase 3
Waitlist Available
Research Sponsored by Allergan
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights
Study Summary
This trial will look at the safety of a drug called Eluxadoline when given to children with IBS-D. The children must have already completed another study on the drug.
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.Check my eligibility
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.See study design
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 belowSelect...
I am between 6 and 17 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants with Adverse Events
Percentage of Participants with Clinically Significant ECGs as assessed by the Investigator
Percentage of Participants with Clinically Significant Laboratory Values (clinical chemistry, complete blood count, urinalysis) as assessed by the Investigator
+3 moreTrial 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
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 V: Double Blind 12-17 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 VI: Double Blind 12-17 years of age: Eluxadoline 25mgExperimental 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 VII: Double Blind 12-17 years of age: Eluxadoline 100mgExperimental 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
Find a Location
Who is running the clinical trial?
AllerganLead Sponsor
781 Previous Clinical Trials
276,445 Total Patients Enrolled
6 Trials studying Irritable Bowel Syndrome
1,236 Patients Enrolled for Irritable Bowel Syndrome
Taryn Weissman, MDStudy DirectorAllergan
2 Previous Clinical Trials
95 Total Patients Enrolled
1 Trials studying Irritable Bowel Syndrome
95 Patients Enrolled for Irritable Bowel Syndrome
ALLERGAN INC.Study DirectorAllergan
75 Previous Clinical Trials
79,135 Total Patients Enrolled
3 Trials studying Irritable Bowel Syndrome
653 Patients Enrolled for Irritable Bowel Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.You currently drink alcohol regularly or excessively, or have a history of alcohol addiction or abuse. You plan to continue drinking alcohol during the study.I have kidney problems or unstable liver, blood, or metabolic conditions.I do not have a gallbladder.I am not pregnant or nursing, nor do I plan to be during the study.You are allergic or hypersensitive to opioids.I am between 6 and 17 years old.I have a history of severe or chronic constipation or related complications.
Research Study Groups:
This trial has the following groups:- Group 1: Open Label 12-17 years of age: Eluxadoline 100 mg
- Group 2: Double Blind 12-17 years of age: Eluxadoline 100mg
- Group 3: Open Label 6-11 years of age: Eluxadoline 50mg
- Group 4: Double Blind 6-11 years of age: Eluxadoline 50mg
- Group 5: Double Blind 12-17 years of age: Eluxadoline 25mg
- Group 6: Double Blind 12-17 years of age: Eluxadoline 50mg
- Group 7: Double Blind 6-11 years of age: Eluxadoline 25mg
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people with the specified medical condition able to participate in this research?
"From the information available on clinicaltrials.gov, it can be deduced that this trial is looking for patients. The original posting date was 8/13/2021 and the most recent update was 9/12/2022."
Answered by AI
Who would be an appropriate candidate to enroll in this research study?
"This trial is looking for 124 patients that suffer from irritable bowel syndrome and are aged 6-17. The most notable requirements for participants are as follows: They must have completed the study's intervention in their lead-in study and be either male or female."
Answered by AI
Is 100mg Eluxadoline a common dosage for this type of medication?
"At the moment, there are 3 different trials underway that involve 100mg Eluxadoline. Out of those 3, 2 have progressed to Phase 3. Even though most of the trials for 100mg Eluxadoline take place in Cleveland, Ohio,130 locations across America are running these sorts of tests."
Answered by AI
Would patients who are elderly be able to safely participate in this clinical trial?
"This particular clinical trial is only testing the efficacy of the medication on patients aged 6 to 17. Out of the 1087 trials for people over 65 and 415 trials for those under 18, this is one of the latter."
Answered by AI
What are the Eluxadoline risks for people at the 100mg dosage?
"Eluxadoline has been studied in Phase 3 trials, meaning that there is some data supporting efficacy and multiple rounds of data supporting safety. Our team rates the safety of 100mg Eluxadoline as a 3 on our 1-to-3 scale."
Answered by AI
Are patients in this city able to receive this treatment at many different locations?
"Among other places, this trial is being conducted by IPS Research Company in Oklahoma City, Oklahoma; Kindred Medical Institute, LLC /ID# 227595 in Corona, California; and Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 227600 in Stockbridge, Georgia."
Answered by AI
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