Irritable Bowel Syndrome Clinical Trial
Official title:
A Phase 3, Long-term Safety Study of Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)
Verified date | June 2024 |
Source | AbbVie |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 124 |
Est. completion date | March 15, 2027 |
Est. primary completion date | March 15, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 17 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Florida Research Center, Inc. /ID# 227597 | Miami | Florida |
United States | IPS Research Company /ID# 227594 | Oklahoma City | Oklahoma |
United States | Preferred Primary Care Physicians, Inc. /ID# 227596 | Pittsburgh | Pennsylvania |
United States | Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 227600 | Stockbridge | Georgia |
Lead Sponsor | Collaborator |
---|---|
AbbVie |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants with Adverse Events | 52 weeks | ||
Primary | Percentage of Participants with Clinically Significant Laboratory Values (clinical chemistry, complete blood count, urinalysis) as assessed by the Investigator | 52 weeks | ||
Primary | Percentage of Participants with Clinically Significant ECGs as assessed by the Investigator | 52 weeks | ||
Primary | Percentage of Participants with Clinically Significant vital sign measurements as assessed by the Investigator | 52 weeks | ||
Primary | Percentage of Participants with any new Physical examination abnormality or worsening of change from baseline | 52 weeks | ||
Primary | Percentage of Participants with any new neurological abnormality post baseline or worsening of change from baseline | 52 weeks |
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