This study will assess the long-term safety of oral Eluxadoline administered to pediatric participants with IBS-D who have completed study intervention in the Phase 2 study 3030-202-002 or the Phase 3 study 3030-303-002.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
124
Oral Tablets
Oral Tablets
Kindred Medical Institute, LLC /ID# 227595
Corona, California, United States
Valencia Medical & Research Center /ID# 246221
Miami, Florida, United States
Florida Research Center, Inc. /ID# 227597
Miami, Florida, United States
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 227600
Stockbridge, Georgia, United States
Percentage of Participants with Adverse Events
Time frame: 52 weeks
Percentage of Participants with Clinically Significant Laboratory Values (clinical chemistry, complete blood count, urinalysis) as assessed by the Investigator
Time frame: 52 weeks
Percentage of Participants with Clinically Significant ECGs as assessed by the Investigator
Time frame: 52 weeks
Percentage of Participants with Clinically Significant vital sign measurements as assessed by the Investigator
Time frame: 52 weeks
Percentage of Participants with any new Physical examination abnormality or worsening of change from baseline
Time frame: 52 weeks
Percentage of Participants with any new neurological abnormality post baseline or worsening of change from baseline
Time frame: 52 weeks
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IPS Research Company /ID# 227594
Oklahoma City, Oklahoma, United States
Preferred Primary Care Physicians, Inc. /ID# 227596
Pittsburgh, Pennsylvania, United States