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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
Sponsor:
Information provided by (Responsible Party):
Stanford University

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.


Condition or disease
Gout

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Study Type : Observational [Patient Registry]
Actual Enrollment : 185 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout
MedlinePlus related topics: Gout
Drug Information available for: Colchicine

Group/Cohort
Diagnosis with Gout and use of colchicine
Observational study age 18+



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All adults diagnosed with gout. Patient's from Stanford hospital and clinics and VA Palo Alto Heath care system are eligible
Criteria

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


Information from the National Library of Medicine

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


Locations
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United States, California
Stanford Hospital and Clinics
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Additional Information:

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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT02000232    
Other Study ID Numbers: 1U01FD004257-01 ( U.S. FDA Grant/Contract )
First Posted: December 4, 2013    Key Record Dates
Last Update Posted: August 10, 2022
Last Verified: August 2022
Keywords provided by Stanford University:
gout
colchicine