RecruitingIrritable Bowel Syndrome

Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children

Eligible age

6–17 yrs

Accepts

All genders

Locations

14 states

Healthy volunteers

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About this study

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.

Sponsor: AbbVie

You may qualify if…

✓ 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 participants of childbearing potential must have a negative serum pregnancy test at Visit 1 (screening) and a negative urine pregnancy test at Visit 3 (randomization) prior to dosing.
✓ Female participants of childbearing potential must practice at least 1 protocol-specified method of birth control, that is effective from Study Day 1 through at least 30 days after the last dose of study drug. Local practices may require 2 methods of birth control. Female participants of non-childbearing potential do not need to use birth control.
✓ Participant has a diagnosis of IBS-D as defined by the modified Rome IV child/adolescent criteria: Must include all of the following:
✓ \-- Abdominal pain at least 4 days per month over at least 2 months associated with one or more of the following:
✓ Related to defecation

You may not qualify if…

✕ Participant has no gallbladder, (ie, agenesis of the gallbladder or cholecystectomy).
✕ Participant has had any of the following surgeries:
✕ Any abdominal surgery within the 3 months prior to Screening; or
✕ A history of major gastric, hepatic, pancreatic, or intestinal surgery. (Note: appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post-surgery are allowed. For the purposes of this study, laparoscopic surgeries without complication are considered minor and non-exclusionary, provided the condition for which the surgery was performed was not exclusionary.)
✕ Participant has a history of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical GI obstruction or pseudo obstruction.
✕ Participant has a history or current diagnosis of constipation with encopresis.
✕ Participant meets the child/adolescent Rome IV criteria of IBS with constipation, IBS with constipation and diarrhea (mixed), unspecified IBS, or functional constipation.
✕ Participant has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation.