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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 : Unknown
Verified November 2013 by Eswar Krishnan, Stanford University.
Recruitment status was:  Recruiting
First Posted : December 4, 2013
Last Update Posted : December 4, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Study Design

Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gout
Drug Information available for: Colchicine
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Contacts and Locations

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
United States, California
Stanford Hospital and Clinics Recruiting
Stanford, California, United States, 94305
Contact: Narinder Bolaria    650-736-7081    nbolaria@stanford.edu   
Principal Investigator: Eswar Krishnan, MD         
Sponsors and Collaborators
Stanford University
More Information

Responsible Party: Eswar Krishnan, Assistant Professor, Medicine - Immunology & Rheumatology, Stanford University
ClinicalTrials.gov Identifier: NCT02000232     History of Changes
Other Study ID Numbers: 1U01FD004257-01 ( U.S. FDA Grant/Contract )
First Posted: December 4, 2013    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: November 2013

Keywords provided by Eswar Krishnan, Stanford University:
gout
colchicine

Additional relevant MeSH terms:
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents