Impact of Unapproved Drug Initiative on Colchicine Use

Stanford University

Status: Completed

Conditions: Gout

Study type: Observational

Funder types: Other

Identifiers

NCT02000232

1U01FD004257-01

Details and patient eligibility

About

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.

Enrollment: 185 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

185 participants in 1 patient group

Diagnosis with Gout and use of colchicine

Description:

Observational study age 18+