GoutNCT02000232
Impact of Unapproved Drug Initiative on Colchicine Use
An observational study of Gout, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gout
- How many people
- 185 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Sep 2014
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adults diagnosed with gout. Patient's from Stanford hospital and clinics and VA Palo Alto Heath care system are eligible
Who may be able to join
- Clinical diagnosis of gout
- Current use of colchicine/colcrys to treat gout
- Ablility to provide Informed consent
Who cannot join
- -Inability to provide Informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Hospital and Clinics
Stanford, California, 94305
About this study
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.
- Conditions
- Gout
- Keywords
- gout, colchicine
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diagnosis with Gout and use of colchicine | Observational study age 18+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: This is an oberservational study and patients will be followed for upto 2 years from enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 185 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000232
- Sponsor's protocol ID
- 1U01FD004257-01
- Status last verified
- Aug 2022
- First submitted
- 6 Nov 2013
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Unapproved Drug Initiative on Colchicine Use
- ClinicalTrials.gov ID
- NCT02000232
- Acronym / sponsor ID
- 1U01FD004257-01
- Conditions
- Gout
- Keywords
- gout, colchicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 4 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnosis with Gout and use of colchicine | – | –Observational study age 18+ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults diagnosed with gout. Patient's from Stanford hospital and clinics and VA Palo Alto Heath care system are eligible
Key inclusion criteria (3 listed)
- Clinical diagnosis of gout
- Current use of colchicine/colcrys to treat gout
- Ablility to provide Informed consent
Key exclusion criteria (1 listed)
- -Inability to provide Informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gout, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.