Clinical trial NCT04880876: A Study Evaluating Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)
Official title: A Phase 3, Long-term Safety Study of Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome with Diarrhea IBSD IBS-D Irritable Bowel Syndrome Pediatric
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-05-11
Enrollment: 124
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

Inclusion Criteria:

* Male or female participants must be 6 to 17 years of age (inclusive)
* Participants must have completed study intervention in their lead-in study

Exclusion Criteria:

* Participant has an unresolved AE or a clinically significant finding on a physical examination, vital sign assessment, or neurological assessment along with an ECG or clinical laboratory tests (if results are available by the time of enrollment) that; in the opinion of the investigator, could represent a safety concern or a condition that would be exclusionary, could prevent the participant from performing any protocol assessments, or could confound study assessments.
* Participant has known allergies or hypersensitivity to opioids
* Female participants who are currently pregnant or nursing, or plan to become pregnant or nurse during the clinical study.
* Participant has no gallbladder, (ie, agenesis of the gallbladder or cholecystectomy).
* Participant has known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction
* Participant has a history of pancreatitis; structural diseases of the pancreas, known or suspected pancreatic duct obstruction
* 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 renal impairment or an unstable hepatic, metabolic, or hematologic condition.
* Participant is a current regular alcohol drinker and/or binge drinker\*, and/or has a history of alcoholism, alcohol abuse (eg, binge-drinking\*), or alcohol addiction, and/or intends to consume alcohol during the study

Primary outcomes:
measure: Percentage of Participants with Adverse Events
timeFrame: 52 weeks
measure: Percentage of Participants with Clinically Significant Laboratory Values (clinical chemistry, complete blood count, urinalysis) as assessed by the Investigator
timeFrame: 52 weeks
measure: Percentage of Participants with Clinically Significant ECGs as assessed by the Investigator
timeFrame: 52 weeks
measure: Percentage of Participants with Clinically Significant vital sign measurements as assessed by the Investigator
timeFrame: 52 weeks
measure: Percentage of Participants with any new Physical examination abnormality or worsening of change from baseline
timeFrame: 52 weeks
measure: Percentage of Participants with any new neurological abnormality post baseline or worsening of change from baseline
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Florida Research Center, Inc. /ID# 227597
state: Florida
city: Stockbridge
country: United States
facility: Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 227600
state: Georgia
city: Oklahoma City
country: United States
facility: IPS Research Company /ID# 227594
state: Oklahoma
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians, Inc. /ID# 227596
state: Pennsylvania
Study officials:
affiliation: Allergan
name: ALLERGAN INC.
role: STUDY_DIRECTOR
References: