Actively Recruiting
Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children
Led by AbbVie · Updated on 2025-09-19
95
Participants Needed
46
Research Sites
471 weeks
Total Duration
On this page
AI-Summary
What this Trial 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 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.
CONDITIONS
Official Title
Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant provides written or verbal informed assent and parent/guardian provides written informed consent.
- Male or female outpatient aged 6 to 17 years at assent with signed parental consent.
- Able to read and understand eDiary assessments, or caregiver can assist if participant is 6 to 11 years old.
- Female participants must not be pregnant, breastfeeding, or planning pregnancy during the study and 30 days after last dose.
- Females of childbearing potential must have negative pregnancy tests at screening and randomization.
- Females of childbearing potential must use at least one effective birth control method from study start to 30 days after last dose.
- Diagnosed with IBS-D by modified Rome IV child/adolescent criteria including abdominal pain at least 4 days/month over 2 months plus related stool changes.
- Symptoms not explained by another medical condition.
- Predominantly diarrheal stool symptoms with Bristol stool types 6 or 7 for over 25% of bowel movements without laxatives.
- Diagnosis fulfilled for at least 2 months before screening.
- Compliant with eDiary, completing morning and evening assessments for at least 8 of 14 days before randomization.
- Average daytime abdominal pain score ≥1.0 over 2 weeks before randomization.
- At least 1 daytime bowel movement with stool consistency type 6 or 7 on at least 2 days per week during 2 weeks before randomization without laxatives.
You will not qualify if you...
- No gallbladder due to agenesis or cholecystectomy.
- Abdominal surgery within 3 months before screening or major gastric, hepatic, pancreatic, or intestinal surgery history.
- History of chronic or severe constipation, mechanical gastrointestinal obstruction or pseudo obstruction.
- History or current diagnosis of constipation with encopresis.
- Meets Rome IV criteria for IBS with constipation, mixed IBS, unspecified IBS, or functional constipation.
- History of intestinal obstruction, stricture, toxic megacolon, gastrointestinal perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation.
- Documented hepatic impairment (Child-Pugh Grade A, B, or C).
- History or current inflammatory or immune-mediated lower gastrointestinal disorders such as Crohn's disease, ulcerative colitis, or microscopic colitis.
- Celiac disease or positive serology for celiac disease not ruled out by biopsy.
- Congenital or acquired malabsorption syndromes.
- Microbiologically documented gastrointestinal infection within 3 months before screening.
- Known lactose or fructose intolerance causing diarrhea or abdominal discomfort that could affect study assessments.
- History of diverticulitis within 3 months before screening.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 46 locations
1
HealthStar Research of Hot Springs PLLC /ID# 234609
Hot Springs, Arkansas, United States, 71913
Actively Recruiting
2
Applied Research Center of Arkansas /ID# 238070
Little Rock, Arkansas, United States, 72212-4187
Actively Recruiting
3
Kindred Medical Institute, LLC /ID# 237368
Corona, California, United States, 92879
Completed
4
Duplicate_VVCRD Research /ID# 234606
Garden Grove, California, United States, 92845
Completed
5
Duplicate_Center for Clinical Trials LLC /ID# 234630
Paramount, California, United States, 90723
Completed
6
Sunrise Research Institute /ID# 237382
Miami, Florida, United States, 33130
Completed
7
South Miami Medical & Research Group Inc. /ID# 234655
Miami, Florida, United States, 33155
Actively Recruiting
8
Valencia Medical & Research Center /ID# 234672
Miami, Florida, United States, 33165
Actively Recruiting
9
Florida Research Center, Inc. /ID# 236514
Miami, Florida, United States, 33174
Actively Recruiting
10
Duplicate_Wellness Clinical Research /ID# 237401
Miami Lakes, Florida, United States, 33016
Completed
11
Global Research Associates /ID# 234646
Atlanta, Georgia, United States, 30315
Actively Recruiting
12
Children's Ctr Digestive, US /ID# 237575
Atlanta, Georgia, United States, 30342
Completed
13
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 236343
Stockbridge, Georgia, United States, 30281
Actively Recruiting
14
Advocate Children's Hospital-Park Ridge /ID# 235388
Park Ridge, Illinois, United States, 60068
Completed
15
Indiana University Health Riley Hospital for Children /ID# 235400
Indianapolis, Indiana, United States, 46202
Completed
16
Michael W. Simon, MD, PSC /ID# 236517
Lexington, Kentucky, United States, 40517
Completed
17
Frederick County Pediatrics /ID# 234519
New Market, Maryland, United States, 21774-6154
Completed
18
MNGI Digestive Health, P. A. /ID# 238057
Minneapolis, Minnesota, United States, 55413-2195
Completed
19
Celen Medical Group Corp /ID# 234922
Marlton, New Jersey, United States, 08053
Completed
20
IPS Research Company /ID# 237672
Oklahoma City, Oklahoma, United States, 73106
Completed
21
Children's Hospital of Philadelphia - Main /ID# 234313
Philadelphia, Pennsylvania, United States, 19104-4319
Completed
22
Preferred Primary Care Physicians, Inc. /ID# 236436
Pittsburgh, Pennsylvania, United States, 15236
Actively Recruiting
23
Cook Children's Med. Center /ID# 237537
Fort Worth, Texas, United States, 76104
Completed
24
Texas Children's Hospital /ID# 238304
Houston, Texas, United States, 77030-2608
Actively Recruiting
25
Sun Research Institute /ID# 236933
San Antonio, Texas, United States, 78215
Completed
26
West Virginia University Hospitals /ID# 256841
Morgantown, West Virginia, United States, 26506
Actively Recruiting
27
Medical center 1 Sevlievo /ID# 237473
Sevlievo, Gabrovo, Bulgaria, 5400
Completed
28
MHATSv.Ivan Rilski /ID# 235399
Kozloduy, Bulgaria, 3320
Completed
29
University Hospital Plovdiv /ID# 235450
Plovdiv, Bulgaria, 4001
Completed
30
Duplicate_Edmonton Clinic Health Academy (ECHA) /ID# 234917
Edmonton, Canada, T6G 1C9
Completed
31
Manitoba Institute of Child Health /ID# 235448
Winnepeg, Canada, R3E 3P4
Completed
32
HELIOS Klinikum Wuppertal /ID# 237322
Wuppertal, Germany, 42283
Completed
33
Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz /ID# 236993
Budapest, Hungary, 1125
Completed
34
Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 237341
Sopron, Hungary, 9400
Completed
35
Vita Verum Medical Bt. /ID# 234321
Székesfehérvár, Hungary, 8000
Completed
36
Duplicate_Academisch Medisch Centrum /ID# 237117
Amsterdam, North Holland, Netherlands, 1105 AZ
Completed
37
Specjalistyczne Gabinety Sp. z o.o. /ID# 236347
Krakow, Lesser Poland Voivodeship, Poland, 30-539
Completed
38
Centrum Zdrowia MDM /ID# 237269
Warsaw, Masovian Voivodeship, Poland, 00-189
Completed
39
Duplicate_Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 234311
Warsaw, Masovian Voivodeship, Poland, 04-730
Completed
40
Korczowski Bartosz Gabinet Lekarski /ID# 234683
Rzeszów, Podkarpackie Voivodeship, Poland, 35-302
Completed
41
Copertnicus Podmiot Leczniczy Sp. z o.o. /ID# 235656
Gdansk, Pomeranian Voivodeship, Poland, 80-803
Completed
42
Instytut Centrum Zdrowia Matki Polki /ID# 237438
Lodz, Łódź Voivodeship, Poland, 93-338
Completed
43
Hospital Universitario Dr. Peset /ID# 236755
Valencia, Spain, 46017
Completed
44
Kings College Hospital NHS Foundation Trust /ID# 236305
London, Greater London, United Kingdom, SE5 9RS
Completed
45
Duplicate_Manchester University NHS Foundation Trust /ID# 234663
Manchester, Lancashire, United Kingdom, M13 9WL
Completed
46
Blackpool Teaching Hospitals NHS Foundation Trust /ID# 237273
Blackpool, United Kingdom, FY3 8NR
Completed
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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