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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 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.

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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.

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

Sponsor

AbbVie

526 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03339128

The ClinicalTrials.gov registry entry for NCT03339128 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 142-participant average among 47 other Irritable Bowel Syndrome trials with a reported enrollment target (33% lower). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.