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RECRUITING Phase 2

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

NCT03339128 · View on ClinicalTrials.gov ↗

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

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

603 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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03339128 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03339128?

The interventions under investigation include: Placebo (DRUG), Eluxadoline (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03339128?

This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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