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NCT02367183 · ClinicalTrials.gov registry record · Phase 1

A Randomized, Double-blind, Study to Explore the Effect of GED-0301 in Subjects With Active Crohn's Disease

A Phase 1 study of Crohn Disease, sponsored by Celgene.

Completed
Registry status
Phase 1
Development phase
64
Enrollment target
20
Study locations

NCT02367183 is a Phase 1 study of Crohn Disease that has completed, run by Celgene. The registered enrollment target is 64 participants, below the 205-participant average among 71 other Crohn Disease trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 7 states.

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The verdict

NCT02367183, a Phase 1 study of Crohn Disease, has completed, sponsored by Celgene.

COMPLETED
Registry status
Phase 1
Development phase
64 participants
Enrollment target
20
Study locations

Study Summary

This study is design to explore the effect of GED-0301 on clinical and endoscopic outcome and to evaluate its safety in subjects with active Crohn's disease.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG GED-0301

Study Locations (20)

Florida

  • Florida Research Network, LLC - Gainesville
  • University of Florida Shands Endoscopy Center University of Florida at Gainesville - Gainesville
  • Borland - Groover Clinic - Jacksonville
  • University of Miami - Miami
  • Gastroenterology Group of Naples - Naples
  • Advanced Medical Research Center - Port Orange
  • Shafran Gastroenterology Center - Winter Park

California

  • Cedars Sinai Medical Center - Los Angeles
  • Macks Research Group - Newport Beach
  • Medical Associates Research Group - San Diego
  • University of California, San Francisco Medical Center - San Francisco

New York

  • NYU Langone Long Island Clinical Research Associates - Great Neck
  • Concorde Medical Group - New York
  • Cornell University - New York

Georgia

  • Atlanta Gastroenterology Associates, LLC - Atlanta
  • Gastroenterology Specialists - Suwanee

Michigan

  • University of Michigan - Ann Arbor
  • Clinical Research Institute of Michigan, LLC - Chesterfield

Kentucky

  • University of Louisville - Louisville

Maryland

  • Metropolitan Gastroenterology - Chevy Chase

Trial Details

FieldValue
Enrollment Target 64 participants
Start Date 2015-04-08
Est. Completion 2017-12-14
Phase Phase 1

Sponsor

Celgene

308 total trials

What the Registry Record Tells You About NCT02367183

The ClinicalTrials.gov registry entry for NCT02367183 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 205-participant average among 71 other Crohn Disease trials with a reported enrollment target (69% lower). The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.

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

NCT02367183 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Florida, California, New York.

Frequently Asked Questions

What is clinical trial NCT02367183 about?

NCT02367183 is a clinical study titled "A Randomized, Double-blind, Study to Explore the Effect of GED-0301 in Subjects With Active Crohn's Disease". This study is design to explore the effect of GED-0301 on clinical and endoscopic outcome and to evaluate its safety in subjects with active Crohn's disease.

What is the current status of trial NCT02367183?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2015-04-08. Estimated completion is 2017-12-14.

What conditions does trial NCT02367183 study?

This clinical trial studies the following conditions: Crohn Disease.

What interventions are being tested in trial NCT02367183?

The interventions under investigation include: Placebo (DRUG), GED-0301 (DRUG).

Who is sponsoring clinical trial NCT02367183?

This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02367183 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Kentucky, Maryland. 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.