A Study Evaluating Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)

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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04880876
• Other study ID #: 3030-302-002
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: August 13, 2021
• Est. completion date: March 15, 2027

Study information

• Verified date: May 2023
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Diarrhea
• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• 25mg Eluxadoline
Oral Tablets
• 100mg Eluxadoline
Oral Tablets

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

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