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 : Unknown
Verified November 2013 by Eswar Krishnan, Stanford University.
Recruitment status was: Recruiting
First Posted : December 4, 2013
Last Update Posted : December 4, 2013
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]|
|Estimated Enrollment :||250 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Impact of Unapproved Drug Initiative on Colchicine Use|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||June 2015|
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||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Narinder Bolaria 650-736-7081 firstname.lastname@example.org|
|Principal Investigator: Eswar Krishnan, MD|