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A Randomized, Double-blind, Study to Explore the Effect of GED-0301 in Subjects With Active Crohn's Disease
NCT02367183 · View on ClinicalTrials.gov ↗
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
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2015-04-08 |
| Est. Completion | 2017-12-14 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02367183
The ClinicalTrials.gov registry entry for NCT02367183 describes a study currently listed as completed. It is categorized as Phase 1, 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 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 73 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 Crohn Disease 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: NCT02367183 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Florida, California, New York. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02367183?
The interventions under investigation include: Placebo (DRUG), GED-0301 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02367183?
This trial is sponsored by Celgene, which has 73 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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