Impact of Unapproved Drug Initiative on Colchicine Use

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Eswar Krishnan, Stanford University
ClinicalTrials.gov Identifier:
NCT02000232
First received: November 6, 2013
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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
Gout

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Impact of Unapproved Drug Initiative on Colchicine Use

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    We expect to understand the impact of regulatory approach to colchicine preparation and how marketing can affect clinical use patterns in the real world.


Estimated Enrollment: 250
Study Start Date: January 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Diagnosis with Gout and use of colchicine
Observational study age 18+

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Eswar Krishnan, Assistant Professor, Medicine - Immunology & Rheumatology, Stanford University
ClinicalTrials.gov Identifier: NCT02000232     History of Changes
Other Study ID Numbers: 1U01FD004257-01
Study First Received: November 6, 2013
Last Updated: November 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Stanford University:
gout
colchicine

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

ClinicalTrials.gov processed this record on September 15, 2014