Impact of Unapproved Drug Initiative on Colchicine Use

N/ACompletedNCT02000232

Stanford University185 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

185

Conditions

Gout

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of gout * Current use of colchicine/colcrys to treat gout * Ablility to provide Informed consent Exclusion Criteria: -Inability to provide Informed consent

Locations (1)

Stanford Hospital and Clinics

Stanford, California, United States

Outcomes

Primary Outcomes

Frequency of use of colchicine in an unapproved fashion in contemporary medical proactice.

We expect to understand the impact of regulatory approach to colchicine preparation and how marketing can affect clinical use patterns in the real world.

Time frame: This is an oberservational study and patients will be followed for upto 2 years from enrollment.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.