NCT03339128 · AbbVie
Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children
What this study is about
The primary objectives of this study are to explore the therapeutic effect of eluxadoline in treating irritable bowel syndrome with diarrhea (IBS-D) in pediatric participants 6-17 years of age, to evaluate the how the drug moves through the body of eluxadoline in pediatric participants with IBS-D, and to evaluate the safety and how well patients handle the treatment of eluxadoline in pediatric participants with IBS-D. Enrollment of 12-17 years old age group is closed, enrollment of the 6-11 years old age group will continue.
View original scientific description
The primary objectives of this study are to explore the therapeutic effect of eluxadoline in treating irritable bowel syndrome with diarrhea (IBS-D) in pediatric participants 6-17 years of age, to evaluate the pharmacokinetics of eluxadoline in pediatric participants with IBS-D, and to evaluate the safety and tolerability of eluxadoline in pediatric participants with IBS-D. Enrollment of 12-17 years old age group is closed, enrollment of the 6-11 years old age group will continue.
Interventions
DRUG
Eluxadoline
Oral tablets
DRUG
Placebo
Oral tablets
Primary outcome measures
Change from baseline in stool consistency averaged over the 4-week Treatment Period
Time frame: Baseline (2 Weeks prior to randomization) to Week 4
Stool consistency will be assessed using the Pediatric Bristol Stool Form Scale (p-BSFS) on a range from 1 (Hard Lumps) to 7 (Watery).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participant must provide written or verbal informed assent and the parent/guardian/LAR must provide written informed consent before the initiation of any study-specific procedures.
- Participant is a male or female outpatient, 6 to 17 years of age inclusive, at the time the participant provides assent for the study and parent/guardian/LAR has provided signed consent.
- Participant is able to read and understand the assessments in the eDiary. If the participant is 6 to 11 years of age and does not meet this criterion, the interviewer-administered version of the eDiary must be used and the parent/guardian/LAR or caregiver who will be administering the interviewer-administered version of the eDiary must be able to read and understand the assessments in the eDiary and must undergo training.
- Female participants must not be pregnant, breastfeeding, or considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug. Female
Where
- Hot Springs, Arkansas
- Little Rock, Arkansas
- Corona, California
- Garden Grove, California
- Paramount, California
- Miami, Florida
- Miami Lakes, Florida
- Atlanta, Georgia
- Stockbridge, Georgia
- Park Ridge, Illinois
- Indianapolis, Indiana
- Lexington, Kentucky
And 10 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 19, 2025 · Source of record for eligibility and locations