Impact of Unapproved Drug Initiative on Colchicine Use

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02000232

Enrollment

185

Registered

2013-12-04

Start date

2013-01-31

Completion date

2014-09-30

Last updated

2022-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gout

Keywords

gout, colchicine

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results