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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2024
• Main ID: NCT03339128
• Date of registration: 08/11/2017
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children
• Scientific title: A 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)
• Date of first enrolment: November 15, 2017
• Target sample size: 95
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03339128
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

Bulgaria, Canada, Finland, Germany, Hungary, Italy, Netherlands, Norway, Poland, Spain, United Kingdom, United States

Contacts

• Name: ABBVIE CALL CENTER

• Name: ABBVIE INC.
• Affiliation: AbbVie

Key inclusion & exclusion 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 must not be pregnant, breastfeeding, or considering becoming
pregnant during the study or for approximately 30 days after the last dose of study
drug. 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 of childbearing potential must practice at least 1
protocol-specified method of birth control, that is effective from Study Day 1 through
at least 30 days after the last dose of study drug. Local practices may require 2
methods of birth control. Female participants of non-childbearing potential do not
need to use birth control.

- 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.

- Participant may be newly diagnosed with IBS-D by the investigator at Visit 1. All
criteria for diagnosis must be 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 score greater than or equal to 1.0
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 immediately prior to randomization and that occurs in the absence
of laxatives.

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.



Age minimum: 6 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Irritable Bowel Syndrome

Intervention(s)

Drug: Placebo

Drug: Eluxadoline

Primary Outcome(s)

Change from baseline in stool consistency averaged over the 4-week Treatment Period [Time Frame: Baseline (2 Weeks prior to randomization) to Week 4]

Secondary Outcome(s)

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 for daytime, nighttime, and 24-hour bowel movement frequency [Time Frame: Baseline (2 Weeks prior to randomization) to Week 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 for daytime, nighttime, and 24-hour abdominal pain scores [Time Frame: Baseline (2 Weeks prior to randomization) to Week 4]

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]

Secondary ID(s)

3030-202-002

2017-003770-14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors