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NCT02000232 Clinical Trial

Impact of Unapproved Drug Initiative on Colchicine Use

Gout Clinical Trial

Official title:
Impact of Unapproved Drug Initiative on Colchicine Use

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02000232
Other study ID # 1U01FD004257-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2013
Est. completion date September 2014

Study information
Verified date August 2022
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 185
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Stanford Hospital and Clinics Stanford California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency of use of colchicine in an unapproved fashion in contemporary medical proactice. We expect to understand the impact of regulatory approach to colchicine preparation and how marketing can affect clinical use patterns in the real world. This is an oberservational study and patients will be followed for upto 2 years from enrollment.
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