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Impact of Unapproved Drug Initiative on Colchicine Use

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT02000232
Collaborator
(none)
185
Enrollment
1
Location
20
Actual Duration (Months)
9.3
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    185 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Impact of Unapproved Drug Initiative on Colchicine Use
    Actual Study Start Date :
    Jan 1, 2013
    Actual Primary Completion Date :
    Sep 1, 2014
    Actual Study Completion Date :
    Sep 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    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. [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Stanford Hospital and Clinics Stanford California United States 94305

    Sponsors and Collaborators

    • Stanford University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stanford University
    ClinicalTrials.gov Identifier:
    NCT02000232
    Other Study ID Numbers:
    • 1U01FD004257-01
    First Posted:
    Dec 4, 2013
    Last Update Posted:
    Aug 10, 2022
    Last Verified:
    Aug 1, 2022
    Keywords provided by Stanford University
    gout
    colchicine

    Study Results

    No Results Posted as of Aug 10, 2022