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Impact of Unapproved Drug Initiative on Colchicine Use

Information source: Stanford University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gout

Phase: N/A

Status: Recruiting

Sponsored by: Stanford University

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.

Clinical Details

Official title: Impact of Unapproved Drug Initiative on Colchicine Use

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: Frequency of use of colchicine in an unapproved fashion in contemporary medical proactice.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Stanford Hospital and Clinics, Stanford, California 94305, United States; Recruiting
Narinder Bolaria, Phone: 650-736-7081, Email: nbolaria@stanford.edu
Eswar Krishnan, MD, Principal Investigator
Additional Information

Starting date: January 2013
Last updated: November 26, 2013

Page last updated: August 20, 2015

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