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)

Allergan LTD0 sites120 target enrollmentDecember 13, 2018

Overview

No summary available.

Registry

who.int

Start Date

December 13, 2018

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Allergan LTD

•To be eligible to participate in the study, patients must meet the following criteria:
•1\. Patient 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.
•2\. Patient is a male or female outpatient, 12 to 17 years of age inclusive, at the time the patient provides assent for the study and parent/guardian/LAR has provided signed consent.
•3\. Patient is able to read and understand the assessments in the eDiary.
•4\. Female patients 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.
•5\. Female patients 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:
•a) Hormonal contraception (eg, oral contraceptive, contraceptive implant, or injectable hormonal contraceptive).
•b) Double\-barrier method (eg, condom plus intrauterine device, diaphragm plus spermicide).
•6\. Patient has a diagnosis of IBS\-D as defined by the modified Rome IV child/adolescent criteria\*: Must include all of the following:
•1\. Abdominal pain at least 4 days per month over at least 2 months associated

•Patients who meet any of the following criteria will not be eligible to participate in the study:
•1\.has no gallbladder
•2\.has had any of the following surgeries:
•a)Any abdominal surgery within the 3 months prior to trial;
•b)A history of major gastric, hepatic, pancreatic, or intestinal surgery
•3\.has known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction
•4\.has a history of pancreatitis; structural diseases of the pancreas, known or
•suspected pancreatic duct obstruction
•5\.has a history of cholecystitis within 6months before trial.
•6\.has known or suspected bile acid malabsorption.