Impact of Unapproved Drug Initiative on Colchicine Use
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02000232|
Recruitment Status : Completed
First Posted : December 4, 2013
Last Update Posted : August 10, 2022
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.
|Condition or disease|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||185 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Impact of Unapproved Drug Initiative on Colchicine Use|
|Actual Study Start Date :||January 2013|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
Diagnosis with Gout and use of colchicine
Observational study age 18+
- 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. ]We expect to understand the impact of regulatory approach to colchicine preparation and how marketing can affect clinical use patterns in the real world.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02000232
|United States, California|
|Stanford Hospital and Clinics|
|Stanford, California, United States, 94305|