Intercritical GoutPhase 4NCT01451645
Efficacy and Safety of Colchicine for the Prevention of Gout Flares During the Initiation of Allopurinol
A Phase 4 study testing Colchicine (Colcrys®) and allopurinol in people with Intercritical Gout, run by Regeneron Pharmaceuticals at 37 sites in United States.
Trial summary
The purpose of this study is to determine if once-daily treatment with colchicine, compared to placebo, is effective in preventing gout flares in patients who are initiating therapy with allopurinol. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intercritical Gout
- What is being tested?
- Colchicine (Colcrys®) and allopurinol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 37 sitesUnited States
- Study dates
- Oct 2011to Sep 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria include, but are not limited to the following:
- Men and postmenopausal women between the ages of 18 and 70
- Meets the ARA criteria for classification of acute gout
- Tophi present and/or a history of gout attacks in 2 or 3 joints
- Self-reported history of at least 2 gout flares in the prior 12 months
- Serum uric acid greater than or equal to 7.5 mg/dL at the first visit
Who cannot join
- Exclusion criteria include, but are not limited to the following:
- Patients with an acute gout flare within 2 weeks prior to the first visit
- Patients with chronic, active gout with at least 1 continuously inflamed joint for at least 4 weeks
- Patients with more than three joints affected by gout
- History of intolerance or allergy to colchicine or allopurinol
- Use of allopurinol, benzbromarone, febuxostat, probenecid, or sulfinpyrazone less than 3 months prior to entering the study
- Use of colchicine less than 14 days prior to entering the study
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
United States37 sites
Study site
Alabaster, Alabama
Study site
Albuquerque, New Mexico
Study site
Bethesda, Maryland
Study site
Billings, Montana
Study site
Bingham Farms, Michigan
Study site
Boise, Idaho
Study site
Brooklyn Center, Minnesota
Study site
Canton, Georgia
Study site
Charlotte, North Carolina
Study site
Dallas, Texas
Study site
DeBary, Florida
Study site
Duncansville, Pennsylvania
Study site
Elizabeth, New Jersey
Study site
Greer, South Carolina
Study site
Hickory, North Carolina
Study site
Jacksonville, Florida
Study site
Johnson City, Tennessee
Study site
Kansas City, Missouri
Study site
Katy, Texas
Study site
Kissimmee, Florida
Study site
Lexington, Kentucky
Study site
Mesa, Arizona
Study site
Morganton, North Carolina
Study site
Mt. Pleasant, South Carolina
Study site
New York, New York
Study site
Norfolk, Virginia
Study site
Reading, Pennsylvania
Study site
Reisterstown, Maryland
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
Seattle, Washington
Study site
Trumbull, Connecticut
Study site
Upland, California
Study site
Wauwatosa, Wisconsin
Study site
West Jordan, Utah
Study site
West Reading, Pennsylvania
Study site
Winston-Salem, North Carolina
About this study
The purpose of this study is to determine if once-daily treatment with colchicine, compared to placebo, is effective in preventing gout flares in patients who are initiating therapy with allopurinol.
- Conditions
- Intercritical Gout
- Being tested
- Colchicine (Colcrys®), placebo, allopurinol
- Keywords
- Gout
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine (Colcrys®)Drug
daily 0.6 mg colchicine dosing for 16 weeks
placeboDrug
daily placebo dosing for 16 weeks
allopurinolDrug
background therapy
| Study group | Role | What they receive |
|---|---|---|
| placebo | Other | daily placebo dosing for 16 weeks with background allopurinol therapy Receives: Drug: placebo; Drug: allopurinol |
| Colchicine (Colcrys®) | Active comparator | daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy Receives: Drug: Colchicine (Colcrys®); Drug: allopurinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Gout Flares Per Participant From Day 1 to Week 16
Measured: Day 1 to Week 16
Secondary outcomes (3)
Percentage of Participants With at Least 1 Gout Flare From Day 1 to Week 16
Measured: Day 1 to Week 16
Percentage of Participants With at Least 2 Gout Flares From Day 1 to Week 16
Measured: Day 1 to Week 16
Mean Number of Gout Flare Days Per Participant Assessed From Day 1 to Week 16
Measured: Day 1 to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionAug 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intercritical GoutStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01451645
- Sponsor's protocol ID
- IL1T-GA-1103
- Status last verified
- Apr 2014
- First submitted
- 10 Oct 2011
- Last updated
- 12 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Colchicine for the Prevention of Gout Flares During the Initiation of Allopurinol
- ClinicalTrials.gov ID
- NCT01451645
- Acronym / sponsor ID
- IL1T-GA-1103
- Conditions
- Intercritical Gout
- Keywords
- Gout
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 14 Oct 2011 (estimated)
- Results
- Posted 12 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if once-daily treatment with colchicine, compared to placebo, is effective in preventing gout flares in patients who are initiating therapy with allopurinol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Other | Drug: placebo, Drug: allopurinoldaily placebo dosing for 16 weeks with background allopurinol therapy |
| Colchicine (Colcrys®) | Active comparator | Drug: Colchicine (Colcrys®), Drug: allopurinoldaily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and postmenopausal women between the ages of 18 and 70
- Meets the ARA criteria for classification of acute gout
- Tophi present and/or a history of gout attacks in 2 or 3 joints
- Self-reported history of at least 2 gout flares in the prior 12 months
- Serum uric acid greater than or equal to 7.5 mg/dL at the first visit
Key exclusion criteria (7 listed)
- Patients with an acute gout flare within 2 weeks prior to the first visit
- Patients with chronic, active gout with at least 1 continuously inflamed joint for at least 4 weeks
- Patients with more than three joints affected by gout
- History of intolerance or allergy to colchicine or allopurinol
- Use of allopurinol, benzbromarone, febuxostat, probenecid, or sulfinpyrazone less than 3 months prior to entering the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicine (Colcrys®)daily 0.6 mg colchicine dosing for 16 weeks | Drug | Colchicine (Colcrys®) |
| placebodaily placebo dosing for 16 weeks | Drug | placebo |
| allopurinolbackground therapy | Drug | Colchicine (Colcrys®), placebo |
Primary outcome
Number of Gout Flares Per Participant From Day 1 to Week 16
Time frame: Day 1 to Week 16
3 secondary outcomes
Percentage of Participants With at Least 1 Gout Flare From Day 1 to Week 16
Time frame: Day 1 to Week 16
Percentage of Participants With at Least 2 Gout Flares From Day 1 to Week 16
Time frame: Day 1 to Week 16
Mean Number of Gout Flare Days Per Participant Assessed From Day 1 to Week 16
Time frame: Day 1 to Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Clinical Trial Management study director
Regeneron Pharmaceuticals
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colchicine (Colcrys®) and allopurinol in people with Intercritical Gout, run by Regeneron Pharmaceuticals at 37 sites 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 6 inclusion and 7 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 12 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Gout Flares Per Participant From Day 1 to Week 16 (time frame: Day 1 to Week 16). 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 12 May 2014.