At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Eluxadoline (drug), Placebo (drug)
- How long the study runs
- Study runs about 105 months (dates as stated)
- About the drug or intervention
- Eluxadoline — drug: Oral tablets · Placebo — drug: Oral tablets
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 6 Years to 17 Years
- Who
- All
- Number of participants
- 272
- Started
- 2017-11-15
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for irritable bowel syndrome
- • Phase2 - 272 participants
- • 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
Who can take part?
- • Ages 6 Years to 17 Years
- • Diagnosed with irritable bowel syndrome
Where?
- • London - Kings College Hospital NHS Foundation Trust /ID# 236305
- • Manchester - Duplicate_Manchester University NHS Foundation Trust /ID# 234663
- • Blackpool - Blackpool Teaching Hospitals NHS Foundation Trust /ID# 237273
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 6 Years - 17 Years
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ 2 methods of birth control
What the study is looking for
- ✓Participant must provide written or verbal informed assent and the parent/guardian/LAR must provide written informed...
- ✓Participant is a male or female outpatient, 6 to 17 years of age inclusive, at the time the participant provides...
- ✓Participant has a diagnosis of IBS-D as defined by the modified Rome IV child/adolescent criteria: Must include all...
- ✓\-- Abdominal pain at least 4 days per month over at least 2 months associated with one or more of the following:
- ✓Related to defecation
Who cannot take part
- ✗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
- ✗Participant has a history of chronic or severe constipation or sequelae from constipation, or known or suspected...
- ✗Participant has a history or current diagnosis of constipation with encopresis.
See the full criteria
Where Is This Study? (3 UK sites)
Kings College Hospital NHS Foundation Trust /ID# 236305
London SE5 9RS, United Kingdom
Duplicate_Manchester University NHS Foundation Trust /ID# 234663
Manchester M13 9WL, United Kingdom
Blackpool Teaching Hospitals NHS Foundation Trust /ID# 237273
Blackpool FY3 8NR, United Kingdom
