Impact of Unapproved Drug Initiative on Colchicine Use | NCT02000232

Studies
Impact of Unapproved Drug Initiative on Colchicine Use

NCT02000232

Sponsor

Stanford University

Status

Completed

Last Update Posted

Aug 10, 2022Actual

Enrollment

185Actual

Phase

Not provided

Conditions

Gout

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013Actual

Primary Completion Date

Sep 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

Nov 6, 2013

First Submission Date that Met QC Criteria

Nov 26, 2013

First Posted Date

Dec 4, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2022

Last Update Posted Date

Aug 10, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

185Actual

Label	Type	Description	Intervention Names
Diagnosis with Gout and use of colchicine		Observational study age 18+

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of use of colchicine in an unapproved fashion in contemporary medical proactice.	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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All adults diagnosed with gout. Patient's from Stanford hospital and clinics and VA Palo Alto Heath care system are eligible

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford Hospital and Clinics		Stanford	California	94305	United States

Condition Browse Module

MeSH Terms

ID	Term
D006073	Gout

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D000070657	Crystal Arthropathies

Browse Leaves

Not provided

Browse Branches

Not provided