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NCT01451645 · ClinicalTrials.gov registry record · Phase 4
Efficacy and Safety of Colchicine for the Prevention of Gout Flares During the Initiation of Allopurinol
A Phase 4 study of Intercritical Gout, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 82
- Enrollment target
- 20
- Study locations
NCT01451645 is a Phase 4 study of Intercritical Gout that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 82 participants. The trial reports 20 study locations across 17 states.
The verdict
NCT01451645, a Phase 4 study of Intercritical Gout, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 82 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine if once-daily treatment with colchicine, compared to placebo, is effective in preventing gout flares in patients who are initiating therapy with allopurinol.
Conditions Studied
Interventions
- DRUG placebo
- DRUG Colchicine (Colcrys®)
- DRUG allopurinol
Study Locations (20)
Florida
- - DeBary
- - Jacksonville
- - Kissimmee
Maryland
- - Bethesda
- - Reisterstown
Alabama
- - Alabaster
Arizona
- - Mesa
California
- - Upland
Connecticut
- - Trumbull
Georgia
- - Canton
Idaho
- - Boise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2011-10 |
| Est. Completion | 2012-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01451645
The ClinicalTrials.gov registry entry for NCT01451645 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Intercritical Gout appearing as the primary indexed condition, and to 3 interventions - of which placebo is the first listed.
NCT01451645 reports 20 study locations spanning 17 distinct geographic areas - top geographies include Florida, Maryland, Alabama.
Frequently Asked Questions
What is clinical trial NCT01451645 about?
NCT01451645 is a clinical study titled "Efficacy and Safety of Colchicine for the Prevention of Gout Flares During the Initiation of Allopurinol". The purpose of this study is to determine if once-daily treatment with colchicine, compared to placebo, is effective in preventing gout flares in patients who are initiating therapy with allopurinol.
What is the current status of trial NCT01451645?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 82 participants. The study started on 2011-10. Estimated completion is 2012-09.
What conditions does trial NCT01451645 study?
This clinical trial studies the following conditions: Intercritical Gout.
What interventions are being tested in trial NCT01451645?
The interventions under investigation include: placebo (DRUG), Colchicine (Colcrys®) (DRUG), allopurinol (DRUG).
Who is sponsoring clinical trial NCT01451645?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01451645 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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