Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE April 16, 2021
First Posted Date  ICMJE May 11, 2021
Last Update Posted Date November 19, 2021
Actual Study Start Date  ICMJE August 13, 2021
Estimated Primary Completion Date April 28, 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2021)
  • Percentage of Participants with Adverse Events [ Time Frame: 52 weeks ]
  • Percentage of Participants with Clinically Significant Laboratory Values (clinical chemistry, complete blood count, urinalysis) as assessed by the Investigator [ Time Frame: 52 weeks ]
  • Percentage of Participants with Clinically Significant ECGs as assessed by the Investigator [ Time Frame: 52 weeks ]
  • Percentage of Participants with Clinically Significant vital sign measurements as assessed by the Investigator [ Time Frame: 52 weeks ]
  • Percentage of Participants with any new Physical examination abnormality or worsening of change from baseline [ Time Frame: 52 weeks ]
  • Percentage of Participants with any new neurological abnormality post baseline or worsening of change from baseline [ Time Frame: 52 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Evaluating Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)
Official Title  ICMJE A Phase 3, Long-term Safety Study of Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome
Intervention  ICMJE
  • Drug: 25mg Eluxadoline
    Oral Tablets
  • Drug: 100mg Eluxadoline
    Oral Tablets
Study Arms  ICMJE
  • 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.
    Intervention: Drug: 25mg Eluxadoline
  • 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.
    Interventions:
    • Drug: 25mg Eluxadoline
    • Drug: 100mg Eluxadoline
  • 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
    Intervention: Drug: 25mg Eluxadoline
  • 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
    Intervention: Drug: 25mg Eluxadoline
  • 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
    Intervention: Drug: 25mg Eluxadoline
  • 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
    Intervention: Drug: 25mg Eluxadoline
  • 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
    Intervention: Drug: 25mg Eluxadoline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 5, 2021)
124
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 28, 2028
Estimated Primary Completion Date April 28, 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04880876
Other Study ID Numbers  ICMJE 3030-302-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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/
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ALLERGAN INC. Allergan
PRS Account Allergan
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP