drugset / Trial / NCT03339128
Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children
RandomizedParallel-groupTriple-blindTreatment
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. Enrollment of 12-17 years old age group is closed, enrollment of the 6-11 years old age group will continue.
Timeline
- Start
- 2017-11-15
- Primary completion
- 2026-12
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Eluxadoline | Small molecule | 25 mg | Oral |
| Subject | Eluxadoline | Small molecule | 50 mg | Oral |
| Subject | Eluxadoline | Small molecule | 100 mg | Oral |