This study is currently not recruiting participants.

ELX-MD-03: 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)

Investigating an Investigational Medication for Irritable Bowel Syndrome with Diarrhea in Pediatric Patients

Not Recruiting
12 years - 17 years
All
Phase N/A

Brief description of study.

The purpose of this study is to look into the safety or efficacy of eluxadoline in the treatment of Irritable Bowel Syndrome with Diarrhea (IBS-D).

Detailed description of study

The primary objectives of this study are to explore the therapeutic effect of eluxadoline in treating IBS-D in pediatric patients 12-17 years of age, to evaluate the PK of eluxadoline in pediatric patients with IBS-D, and to evaluate the safety and tolerability of eluxadoline in pediatric patients with IBS-D.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Irritable Bowel Syndrome with Diarrhea
  • Age: 12 years - 17 years
  • Gender: All

This study investigates the safety and effectiveness of an investigational medication for treating Irritable Bowel Syndrome with Diarrhea (IBS-D) in children aged 12 to 17. IBS-D is a condition that affects the stomach and intestines, causing stomach pain and diarrhea. The purpose of the study is to see how well the investigational medication works and how safe it is for young patients.

Participants in the study will receive either the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine. The study will also involve evaluating how the investigational medication is processed in the body of the participants.

  • Who can participate: Children aged 12 to 17 years with Irritable Bowel Syndrome with Diarrhea (IBS-D) are eligible to participate.
  • Study details: Participants will receive either the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine.
Updated on 19 Feb 2024. Study ID: 1709411585

Interested in the study?

Select a study center that’s convenient for you, and get in touch with the study team.

Connect with the study team