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NCT03339128 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Irritable Bowel Syndrome, sponsored by AbbVie.

Recruiting
Registry status
Phase 2
Development phase
95
Enrollment target
20
Study locations

NCT03339128: Recruiting Phase 2 study of Irritable Bowel Syndrome, sponsored by AbbVie.

NCT03339128 is a Phase 2 study of Irritable Bowel Syndrome that is actively recruiting participants, run by AbbVie. The registered enrollment target is 95 participants, below the 142-participant average among 47 other Irritable Bowel Syndrome trials with a reported enrollment target (33% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03339128, a Phase 2 study of Irritable Bowel Syndrome, is actively recruiting participants, sponsored by AbbVie.

RECRUITING
Registry status
Phase 2
Development phase
95 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

Stool consistency will be assessed using the Pediatric Bristol Stool Form Scale (p-BSFS) on a range from 1 (Hard Lumps) to 7 (Watery).

Conditions Studied

Irritable Bowel Syndrome

Interventions

  • DRUG Placebo
  • DRUG Eluxadoline

Study Locations (20)

Florida

  • Sunrise Research Institute /ID# 237382 - Miami
  • South Miami Medical & Research Group Inc. /ID# 234655 - Miami
  • Valencia Medical & Research Center /ID# 234672 - Miami
  • Florida Research Center, Inc. /ID# 236514 - Miami
  • Duplicate_Wellness Clinical Research /ID# 237401 - Miami Lakes

California

  • Kindred Medical Institute, LLC /ID# 237368 - Corona
  • Duplicate_VVCRD Research /ID# 234606 - Garden Grove
  • Duplicate_Center for Clinical Trials LLC /ID# 234630 - Paramount

Georgia

  • Global Research Associates /ID# 234646 - Atlanta
  • Children's Ctr Digestive, US /ID# 237575 - Atlanta
  • Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 236343 - Stockbridge

Arkansas

  • HealthStar Research of Hot Springs PLLC /ID# 234609 - Hot Springs
  • Applied Research Center of Arkansas /ID# 238070 - Little Rock

Illinois

  • Advocate Children's Hospital-Park Ridge /ID# 235388 - Park Ridge

Indiana

  • Indiana University Health Riley Hospital for Children /ID# 235400 - Indianapolis

Kentucky

  • Michael W. Simon, MD, PSC /ID# 236517 - Lexington

Maryland

  • Frederick County Pediatrics /ID# 234519 - New Market

Trial Details

FieldValue
Enrollment Target 95 participants
Start Date 2017-11-15
Est. Completion 2026-12
Phase Phase 2
AbbVie

526 total trials

What NCT03339128 shows while recruiting

NCT03339128 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 142-participant average among 47 other Irritable Bowel Syndrome trials with a reported enrollment target (33% lower).

The record links to 1 condition, with Irritable Bowel Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT03339128 names 20 study sites across 11 states, led by Florida, California, Georgia.

Frequently Asked Questions

What is clinical trial NCT03339128 about?

NCT03339128 is a clinical study titled "Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children". 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 ...

What is the current status of trial NCT03339128?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 95 participants. The study started on 2017-11-15. Estimated completion is 2026-12.

What conditions does trial NCT03339128 study?

This clinical trial studies the following conditions: Irritable Bowel Syndrome.

What interventions are being tested in trial NCT03339128?

The interventions under investigation include: Placebo (DRUG), Eluxadoline (DRUG).

Who is sponsoring clinical trial NCT03339128?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03339128 being conducted?

This trial has 20 study locations across Arkansas, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Irritable Bowel Syndrome

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03339128's enrollment target sits among peer trials

95 22nd of 47 higher than 26 of 47 other Irritable Bowel Syndrome trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Irritable Bowel Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT03339128

Source: ClinicalTrials.gov NCT03339128, the US trial registry maintained by the National Library of Medicine. NCT03339128 (small enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.