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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
95
Oral tablets
Oral tablets
HealthStar Research of Hot Springs PLLC /ID# 234609
Hot Springs, Arkansas, United States
RECRUITINGApplied Research Center of Arkansas /ID# 238070
Little Rock, Arkansas, United States
RECRUITINGKindred Medical Institute, LLC /ID# 237368
Corona, California, United States
COMPLETEDDuplicate_VVCRD Research /ID# 234606
Garden Grove, California, United States
Change from baseline in stool consistency averaged over the 4-week Treatment Period
Stool consistency will be assessed using the Pediatric Bristol Stool Form Scale (p-BSFS) on a range from 1 (Hard Lumps) to 7 (Watery).
Time frame: Baseline (2 Weeks prior to randomization) to Week 4
Change from baseline in stool consistency for daily daytime and nighttime stool consistency scores
Stool consistency will be assessed using the Pediatric Bristol Stool Form Scale (p-BSFS) on a range from 1 (Hard Lumps) to 7 (Watery).
Time frame: Baseline (2 Weeks prior to randomization) to Week 4
Change from baseline for daytime, nighttime, and 24-hour abdominal pain scores
Abdominal Pain is scored on a five-point ordinal scale, with 0 meaning no pain, and 4 meaning a lot of pain.
Time frame: Baseline (2 Weeks prior to randomization) to Week 4
Change from baseline for daytime, nighttime, and 24-hour bowel movement frequency
Change from baseline in the number of bowel movements.
Time frame: Baseline (2 Weeks prior to randomization) to Week 4
Change from baseline for daytime, nighttime, and 24 hour urgency-free days
Change from baseline in the number of urgency free days in a week.
Time frame: Baseline (2 Weeks prior to randomization) to Week 4
Change from baseline for daytime, nighttime, and 24 hour number of fecal incontinence-free days
Change from baseline in the number of fecal incontinence-free days in a week.
Time frame: Baseline (2 Weeks prior to randomization) to Week 4
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Duplicate_Center for Clinical Trials LLC /ID# 234630
Paramount, California, United States
COMPLETEDSunrise Research Institute /ID# 237382
Miami, Florida, United States
COMPLETEDSouth Miami Medical & Research Group Inc. /ID# 234655
Miami, Florida, United States
RECRUITINGValencia Medical & Research Center /ID# 234672
Miami, Florida, United States
RECRUITINGFlorida Research Center, Inc. /ID# 236514
Miami, Florida, United States
RECRUITINGDuplicate_Wellness Clinical Research /ID# 237401
Miami Lakes, Florida, United States
COMPLETED...and 36 more locations