A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Safety and Efficacy of Eluxadoline in Pediatric Patients (Age 12 to 17 Years) with Irritable Bowel Syndrome with Diarrhea (IBS-D)

Purpose

To explore the therapeutic effect of eluxadoline in treating IBS-D in pediatric patients 12-17 years of age

To evaluate the pharmacokinetics (PK) of eluxadoline in pediatric patients with IBS-D

To evaluate the safety and tolerability of eluxadoline in pediatric patients with IBS-D

The results of this dose-ranging study will allow the selection of an optimal dose(s) of eluxadoline to evaluate in the subsequent confirmatory efficacy study

Criteria

Male or female outpatient, 12 to 17 years of age

Patient 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

Patient has predominantly diarrheal stool symptoms defined as Bristol stool types 6 or 7 for >25% of bowel movements and Bristol stool types 1 or 2 for <25% of bowel movements that occur in the absence of laxatives

Patient 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

Can not:

Have had gallbladder removed

Have had any of the following surgeries:

Any abdominal surgery within the 3 months prior to Screening; orA history of major gastric, hepatic, pancreatic, or intestinal surgery

Have a history of cholecystitis within 6 months before Screening

Have a history of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical GI obstruction or pseudo obstruction.

Have a history or current diagnosis of inflammatory or immune-mediated GI

disorders including inflammatory bowel disease (ie, Crohn’s disease, ulcerative colitis, microscopic colitis).

Details

Stipend: $50.00/visit plus mileage if traveling over 50 miles roundtrip

Approximately 120 eligible patients will be randomly assigned in a ratio of 1:1:1:1 to 1 of 4 treatment groups as follows: ? Group 1: 25 mg eluxadoline BID for 28 days (n=30)

Group 2: 50 mg eluxadoline BID for 28 days (n=30)

Group 3: 100 mg eluxadoline BID for 28 days (n=30)

Group 4: placebo BID for 28 days (n=30)

Treatments will be administered as oral tablets.

The study will consist of a 1-2-week Screening Period and a 2-3-week Pre-treatment

Period, a 4-week double-blind Treatment Period and a 2-week Post-treatment follow-up Period.  

Interested in more information? Contact Us:

Sunny Hussain, M.D., Principal Investigator
(318) 212-8130

IRB: CGIRB
IRB Number:
Trial Type: Drug
Sponsor: Allergan