Impact of Unapproved Drug Initiative on Colchicine Use

Completed

• Conditions: Gout

• Registration Number: NCT02000232
• Lead Sponsor: Stanford University

Brief Summary

Measure if FDA regulation of Colchicne in 2009 has resulted in safer use in clinical settings.

Our study will assess the impact of this Initiative on colchicine use and will provide data that supports its continuation and expansion.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-11-06
• Study First Submitted QC: 2013-11-26
• Study First Posted: 2013-12-04
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

Inclusion Criteria

• Clinical diagnosis of gout
• Current use of colchicine/colcrys to treat gout
• Ablility to provide Informed consent

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Exclusion Criteria

-Inability to provide Informed consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of use of colchicine in an unapproved fashion in contemporary medical proactice.	This is an oberservational study and patients will be followed for upto 2 years from enrollment.	We expect to understand the impact of regulatory approach to colchicine preparation and how marketing can affect clinical use patterns in the real world.

Trial Locations

Locations (1)

Stanford Hospital and Clinics; 🇺🇸 Stanford, California, United States