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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04880876
Recruitment Status : Recruiting
First Posted : May 11, 2021
Last Update Posted : November 19, 2021
Sponsor:
Information provided by (Responsible Party):
Allergan

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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: 25mg Eluxadoline Drug: 100mg Eluxadoline Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Long-term Safety Study of Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)
Actual Study Start Date : August 13, 2021
Estimated Primary Completion Date : April 28, 2028
Estimated Study Completion Date : April 28, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
Drug Information available for: Eluxadoline

Arm Intervention/treatment
Experimental: Open Label 6-11 years of age: Eluxadoline 50mg
Eluxadoline two 25mg tablets, oral administration, twice daily with food. Take at approximately the same time each day.
Drug: 25mg Eluxadoline
Oral Tablets

Experimental: Open Label 12-17 years of age: Eluxadoline 100 mg
Eluxadoline one 100mg tablet, oral administration, twice daily with food. May use 25mg tablets to administer 100mg dose. Take at approximately the same time each day.
Drug: 25mg Eluxadoline
Oral Tablets

Drug: 100mg Eluxadoline
Oral Tablets

Experimental: Double Blind 6-11 years of age: Eluxadoline 25mg
Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID
Drug: 25mg Eluxadoline
Oral Tablets

Experimental: Double Blind 6-11 years of age: Eluxadoline 50mg
Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID
Drug: 25mg Eluxadoline
Oral Tablets

Experimental: Double Blind 12-17 years of age: Eluxadoline 25mg
Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID
Drug: 25mg Eluxadoline
Oral Tablets

Experimental: Double Blind 12-17 years of age: Eluxadoline 50mg
Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID
Drug: 25mg Eluxadoline
Oral Tablets

Experimental: Double Blind 12-17 years of age: Eluxadoline 100mg
Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID
Drug: 25mg Eluxadoline
Oral Tablets




Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events [ Time Frame: 52 weeks ]
  2. Percentage of Participants with Clinically Significant Laboratory Values (clinical chemistry, complete blood count, urinalysis) as assessed by the Investigator [ Time Frame: 52 weeks ]
  3. Percentage of Participants with Clinically Significant ECGs as assessed by the Investigator [ Time Frame: 52 weeks ]
  4. Percentage of Participants with Clinically Significant vital sign measurements as assessed by the Investigator [ Time Frame: 52 weeks ]
  5. Percentage of Participants with any new Physical examination abnormality or worsening of change from baseline [ Time Frame: 52 weeks ]
  6. Percentage of Participants with any new neurological abnormality post baseline or worsening of change from baseline [ Time Frame: 52 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04880876


Contacts
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Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Locations
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United States, California
Kindred Medical Institute, LLC /ID# 227595 Not yet recruiting
Corona, California, United States, 92879
United States, Florida
Florida Research Center, Inc. /ID# 227597 Recruiting
Miami, Florida, United States, 33174
United States, Georgia
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 227600 Recruiting
Stockbridge, Georgia, United States, 30281
United States, Indiana
Riley Hospital for Children /ID# 227601 Not yet recruiting
Indianapolis, Indiana, United States, 46202
United States, Kentucky
Michael W. Simon, MD, PSC /ID# 227598 Not yet recruiting
Lexington, Kentucky, United States, 40517
United States, Oklahoma
IPS Research Company /ID# 227594 Recruiting
Oklahoma City, Oklahoma, United States, 73106
United States, Pennsylvania
Preferred Primary Care Physicians, Inc. /ID# 227596 Recruiting
Pittsburgh, Pennsylvania, United States, 15236
United States, Texas
Sun Research Institute /ID# 227602 Not yet recruiting
San Antonio, Texas, United States, 78215
Sponsors and Collaborators
Allergan
Investigators
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Study Director: ALLERGAN INC. Allergan
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT04880876    
Other Study ID Numbers: 3030-302-002
First Posted: May 11, 2021    Key Record Dates
Last Update Posted: November 19, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: For details on when studies are available for sharing, please refer to the link below
Access Criteria: To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.
URL: https://vivli.org/ourmember/abbvie/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Allergan:
Irritable Bowel Syndrome with Diarrhea IBSD IBS-D Irritable Bowel Syndrome Pediatric
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Diarrhea
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Eluxadoline
Gastrointestinal Agents