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Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children

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: NCT03339128
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : October 19, 2021
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
The primary objectives of this study are to explore the therapeutic effect of eluxadoline in treating irritable bowel syndrome with diarrhea (IBS-D) in pediatric participants 6-17 years of age, to evaluate the pharmacokinetics of eluxadoline in pediatric participants with IBS-D, and to evaluate the safety and tolerability of eluxadoline in pediatric participants with IBS-D.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: Eluxadoline Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Safety and Efficacy of Eluxadoline in Pediatric Participants (Age 6 to 17 Years) With Irritable Bowel Syndrome With Diarrhea (IBS-D)
Actual Study Start Date : November 15, 2017
Estimated Primary Completion Date : July 28, 2023
Estimated Study Completion Date : August 17, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
Drug Information available for: Eluxadoline

Arm Intervention/treatment
Experimental: Eluxadoline 25mg
Eluxadoline 25mg, oral administration, twice daily
Drug: Eluxadoline
Oral tablets
Other Name: Viberzi, Truberzi

Experimental: Eluxadoline 50mg
Eluxadoline 50mg, oral administration, twice daily
Drug: Eluxadoline
Oral tablets
Other Name: Viberzi, Truberzi

Experimental: Eluxadoline 100mg
Eluxadoline 100mg, oral administration, twice daily
Drug: Eluxadoline
Oral tablets
Other Name: Viberzi, Truberzi

Experimental: Placebo
Dose-matched placebo, oral administration, twice daily
Drug: Placebo
Oral tablets




Primary Outcome Measures :
  1. Change from baseline in stool consistency averaged over the 4-week Treatment Period [ Time Frame: Baseline (2 Weeks prior to randomization) to Week 4 ]
    Stool consistency will be assessed using the Pediatric Bristol Stool Form Scale (p-BSFS) on a range from 1 (Hard Lumps) to 7 (Watery).


Secondary Outcome Measures :
  1. Change from baseline in stool consistency for daily daytime and nighttime stool consistency scores [ Time Frame: Baseline (2 Weeks prior to randomization) to Week 4 ]
    Stool consistency will be assessed using the Pediatric Bristol Stool Form Scale (p-BSFS) on a range from 1 (Hard Lumps) to 7 (Watery).

  2. Change from baseline for daytime, nighttime, and 24-hour abdominal pain scores [ Time Frame: Baseline (2 Weeks prior to randomization) to Week 4 ]
    Abdominal Pain is scored on a five-point ordinal scale, with 0 meaning no pain, and 4 meaning a lot of pain.

  3. Change from baseline for daytime, nighttime, and 24-hour bowel movement frequency [ Time Frame: Baseline (2 Weeks prior to randomization) to Week 4 ]
    Change from baseline in the number of bowel movements.

  4. Change from baseline for daytime, nighttime, and 24 hour urgency-free days [ Time Frame: Baseline (2 Weeks prior to randomization) to Week 4 ]
    Change from baseline in the number urgency free days in a week.

  5. Change from baseline for daytime, nighttime, and 24 hour number of fecal incontinence-free days [ Time Frame: Baseline (2 Weeks prior to randomization) to Week 4 ]
    Change from baseline in the number of fecal incontinence-free days in a week.



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:

  • Participant must provide written or verbal informed assent and the parent/guardian/LAR must provide written informed consent before the initiation of any study-specific procedures.
  • Participant is a male or female outpatient, 6 to 17 years of age inclusive, at the time the participant provides assent for the study and parent/guardian/LAR has provided signed consent.
  • Participant is able to read and understand the assessments in the eDiary. If the participant is 6 to 11 years of age and does not meet this criterion, the interviewer-administered version of the eDiary must be used and the parent/guardian/LAR or caregiver who will be administering the interviewer-administered version of the eDiary must be able to read and understand the assessments in the eDiary and must undergo training.
  • Female participants of childbearing potential must have a negative serum pregnancy test at Visit 1 (screening) and a negative urine pregnancy test at Visit 3 (randomization) prior to dosing.
  • Female participants who have had their first menstrual period and are sexually active must agree to use a reliable form of contraception. Reliable contraception is defined as:

    • Hormonal contraception (eg, oral contraceptive, contraceptive implant, or injectable hormonal contraceptive).
    • Double-barrier method (eg, condom plus intrauterine device, diaphragm plus spermicide).
  • Participant has a diagnosis of IBS-D as defined by the modified Rome IV child/adolescent criteria: Must include all of the following:

    -- Abdominal pain at least 4 days per month over at least 2 months associated with one or more of the following:

    • Related to defecation
    • A change in frequency of stool
    • A change in form (appearance) of stool

      • After appropriate evaluation, the symptoms cannot be fully explained by another medical condition.
      • Participant has predominantly diarrheal stool symptoms defined as Bristol stool types 6 or 7 for more than 25% of bowel movements and Bristol stool types 1 or 2 for less than 25% of bowel movements that occur in the absence of laxative.
    • All criteria fulfilled for at least 2 months prior to Visit 1 (screening).
  • Participant has been compliant with the eDiary by completing both the morning and evening assessments for at least 8 out of the 14 days immediately preceding Visit 3 (randomization).
  • Participant has an average daytime abdominal pain scoreless than or equal to 2.0 over the 2 weeks prior to randomization.
  • Participant has at least 1 daytime bowel movement with a consistency of Type 6 or Type 7 on the pediatric Bristol Stool Form Scale (p-BSFS) on at least 2 days per week during the 2 weeks prior to randomization that occurs in the absence of laxatives.
  • Participant has no clinically significant findings on a physical examination, vital sign assessment, electrocardiogram (ECG), and clinical laboratory tests (clinical chemistry panel, liver biochemical tests, complete blood count, urine drug screen, urinalysis) after providing informed assent and after written consent is obtained, but before receiving the first dose of study treatment. (A central laboratory will be used to evaluate all urine [except urine pregnancy tests] and blood samples and will utilize reference ranges specific to a patient's age and gender. ECGs will be performed and electronically transmitted to a central ECG laboratory for analysis by a pediatric cardiologist in accordance with the instructions provided by the central ECG laboratory. The Investigator will determine if a particular finding is clinically significant. [In making this determination, the Investigator will consider whether the particular finding could represent a condition that would exclude the participant from the study, could represent a safety concern if the participant participates in the study, or could confound the study-specific assessments of safety or efficacy.])

Exclusion Criteria:

  • Participant has no gallbladder, (ie, agenesis of the gallbladder or cholecystectomy).
  • Participant has had any of the following surgeries:

    • Any abdominal surgery within the 3 months prior to Screening; or
    • A history of major gastric, hepatic, pancreatic, or intestinal surgery. (Note: appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post-surgery are allowed. For the purposes of this study, laparoscopic surgeries without complication are considered minor and non-exclusionary, provided the condition for which the surgery was performed was not exclusionary.)
  • 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 a history or current diagnosis of constipation with encopresis.
  • Participant meets the child/adolescent Rome IV criteria of IBS with constipation, IBS with constipation and diarrhea (mixed), unspecified IBS, or functional constipation.
  • Participant has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation.
  • Participant has a documented history of hepatic impairment as defined by Child-Pugh Classification Grade A, B or C.
  • Participant has a history or current diagnosis of inflammatory or immune-mediated lower GI disorders including inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, microscopic colitis). Crohn's disease affecting the upper GI tract would also be exclusionary.
  • Participant has celiac disease, or a positive serological test for celiac disease and the condition has not been ruled out by endoscopic biopsy.
  • Participant has any congenital and/or acquired malabsorption syndrome (eg, Shwachman-Diamond syndrome).
  • Participant has a history of a microbiologically documented (ie, stool culture or medical history) GI infection within 3 months prior to Screening.
  • Participant has a known lactose or fructose intolerance that is associated with diarrhea, abdominal pain or discomfort, and that could confound assessments in the study.
  • Participant has a history of diverticulitis within 3 months prior to Screening.

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): NCT03339128


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

Locations
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Sponsors and Collaborators
Allergan
Investigators
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Study Director: ALLERGAN INC. Allergan
Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03339128    
Other Study ID Numbers: 3030-202-002
2017-003770-14 ( EudraCT Number )
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: October 19, 2021
Last Verified: October 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: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
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