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NCT01386112 · ClinicalTrials.gov registry record · Phase 1

Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis

A Phase 1 study of Eosinophilic Esophagitis, sponsored by Forest Laboratories.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target
7
Study locations

NCT01386112 is a Phase 1 study of Eosinophilic Esophagitis that has completed, run by Forest Laboratories. The registered enrollment target is 24 participants, below the 864-participant average among 44 other Eosinophilic Esophagitis trials with a reported enrollment target (97% lower). The trial reports 7 study locations across 7 states.

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The verdict

NCT01386112, a Phase 1 study of Eosinophilic Esophagitis, has completed, sponsored by Forest Laboratories.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target
7
Study locations

Study Summary

Eosinophilic esophagitis (EoE) is an inflammatory disease of the esophagus, characterized by eosinophilic infiltration and gastrointestinal (GI) symptoms. There are no pharmacological treatments for EoE approved by the US Food and Drug Administration (FDA). Supported by published case series and controlled trials in children and adults, the most widely used drug treatment for EoE is off-label use of corticosteroids intended for local (esophageal mucosal) action. This study will evaluate the safety and tolerability of orally administered EUR-1100 once or twice daily. Eligible subjects will be randomized into one of the 3 treatment groups. The Treatment Period will be 8 weeks during which subjects will visit the clinic at the screening visit, randomization, week 4, 8 and 1 week after end of treatment for clinical symptom assessment and safety evaluation. Additional phone visits will occur at week 2 and week 6.

Conditions Studied

Eosinophilic Esophagitis

Interventions

  • DRUG placebo
  • DRUG EUR-1100

Study Locations (7)

Georgia

  • Children's Center for Digestive Health - Atlanta

Illinois

  • Northwestern University School of Medicine - Chicago

Indiana

  • Riley Hospital for Children - Indianapolis

Minnesota

  • Mayo Clinic - Rochester

New Jersey

  • South Jersey Pediatric Gastroenterology - Mays Landing

Pennsylvania

  • University of Pennsylvania - Philadelphia

Virginia

  • O&O Alpan LLC Center for Clinical Trials - Fairfax

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2011-09
Est. Completion 2012-10
Phase Phase 1

Sponsor

Forest Laboratories

145 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01386112

The ClinicalTrials.gov registry entry for NCT01386112 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 864-participant average among 44 other Eosinophilic Esophagitis trials with a reported enrollment target (97% lower). The listed sponsor is Forest Laboratories, which has 145 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Eosinophilic Esophagitis appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.

NCT01386112 reports 7 study locations spanning 7 distinct geographic areas - top geographies include Georgia, Illinois, Indiana.

Frequently Asked Questions

What is clinical trial NCT01386112 about?

NCT01386112 is a clinical study titled "Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis". Eosinophilic esophagitis (EoE) is an inflammatory disease of the esophagus, characterized by eosinophilic infiltration and gastrointestinal (GI) symptoms. There are no pharmacological treatments for EoE approved by the US Food and Drug Administration (FDA). Supported by published case series and con...

What is the current status of trial NCT01386112?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2011-09. Estimated completion is 2012-10.

What conditions does trial NCT01386112 study?

This clinical trial studies the following conditions: Eosinophilic Esophagitis.

What interventions are being tested in trial NCT01386112?

The interventions under investigation include: placebo (DRUG), EUR-1100 (DRUG).

Who is sponsoring clinical trial NCT01386112?

This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01386112 being conducted?

This trial has 7 study locations across Georgia, Illinois, Indiana, Minnesota, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.