Impact of Unapproved Drug Initiative on Colchicine Use
Recruitment status was: Recruiting
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 [Patient Registry]|
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Target Follow-Up Duration:||2 Years|
|Official Title:||Impact of Unapproved Drug Initiative on Colchicine Use|
- Frequency of use of colchicine in an unapproved fashion in contemporary medical proactice. [ Time Frame: This is an oberservational study and patients will be followed for upto 2 years from enrollment. ] [ Designated as safety issue: Yes ]We expect to understand the impact of regulatory approach to colchicine preparation and how marketing can affect clinical use patterns in the real world.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Diagnosis with Gout and use of colchicine
Observational study age 18+
Please refer to this study by its ClinicalTrials.gov identifier: NCT02000232
|United States, California|
|Stanford Hospital and Clinics|
|Stanford, California, United States, 94305|