Impact of Unapproved Drug Initiative on Colchicine Use

August 8, 2022 updated by: Stanford University

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

185

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford Hospital and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
This is an oberservational study and patients will be followed for upto 2 years from enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

November 6, 2013

First Submitted That Met QC Criteria

November 26, 2013

First Posted (Estimate)

December 4, 2013

Study Record Updates

Last Update Posted (Actual)

August 10, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1U01FD004257-01 (U.S. FDA Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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