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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

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

Study information

Verified date June 2024
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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
AbbVie

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
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