Gout showdown: which treatment strategy wins?
NCT ID NCT04875702
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing two common ways to manage gout: one that aims to lower uric acid levels to a specific target, and another that treats flare symptoms as they happen. Researchers will track 650 adults with gout over two years to see which approach leads to fewer gout attacks and better overall health. The goal is to find out which strategy works best for patients in everyday care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Allopurinol (a medication to lower uric acid), along with anti-inflammatory drugs (naproxen, colchicine, prednisone) for symptom control
- What this could lead to
- If successful, this trial could show that one approach to managing gout is clearly better than the other, helping doctors and patients choose the most effective strategy to reduce painful flares and improve quality of life.
- What could go wrong
- This is a phase 4 trial comparing existing strategies, not testing a new breakthrough treatment. The results may show no major difference between the two approaches, or the benefits may vary widely among individuals.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 650 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2024
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
To be eligible to be enrolled in the study, each patient must: 1. Provide signed written or electronic informed consent. 2. Be between 18 and 90 years old. 3. Be in a participating primary care practice with at least one visit in the previous 36 months. 4. Be diagnosed with gout by the 2015 ACR/EULAR criteria, with 8 or more points on the 2015 ACR/EULAR criteria scoring algorithm. 5. Have experienced at least one gout flare attributed in the previous 12 months. 6. Have a baseline inter-critical serum urate (SU) ≥ 6.0 mg/dL (at screening or in the 30 days before screening) 7. Be able to swallow pills. 8. Agree to practice effective measures of birth control if of reproductive potential. Exclusion Criteria Candidates who meet any of the following criteria will be excluded from the study: 1. Diagnosis of CKD Stage 3B or worse (eGFR \< 45 mL/min/ 1.73 m2) at screening 2. More than one subcutaneous tophus on clinical examination at screening 3. Two or more episodes of renal colic in the past 5 years 4. Unable to provide informed consent. 5. AST/ALT \> 3 × upper limit of normal (ULN) (within 6 months of entry). 6. Pregnancy, planning pregnancy, or breastfeeding. 7. Patients who have been treated with thiopurines (mercaptopurine (PURINETHOL®), azathioprine (IMURAN®), or thioguanine) in the past 12 months or currently being treated with thiopurines are not eligible for the study. Usage of the thiopurines (azathioprine and mercaptopurine) with allopurinol has been shown to cause a significant drug-drug interaction. 8. Unlikely to survive 2 years because of comorbidities. 9. Currently taking \> 200 mg of allopurinol per day or any dose of febuxostat. Patients taking 200 mg or less of allopurinol daily may participate, provided they meet the eligibility criteria for flares and current SU, and they have not had a dose escalation in their allopurinol in the previous 6 months. 10. Patients with known allergic or hypersensitive reactions to allopurinol and not willing to initiate febuxostat if urate lowering is indicated. 11. Subjects that test positive for HLA-B\*5801 allele, a genetic marker for severe cutaneous adverse reactions caused by allopurinol and are unwilling to initiate febuxostat if urate lowering is indicated by the study. Subjects of higher risk, including Black/African American, Asian (except Japanese), native Hawaiian, or Pacific Islander descent will be tested at screening.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Boston Medical Center (BMC)
NOT_YET_RECRUITINGBoston, Massachusetts, 02119, United States
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Brigham and Women's Hospital (BWH)
RECRUITINGBoston, Massachusetts, 02115, United States
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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NYU Langone
RECRUITINGNew York, New York, 10010, United States
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The University of Alabama at Birmingham
NOT_YET_RECRUITINGSouth Birmingham, Alabama, 35233, United States
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UCLA Health
NOT_YET_RECRUITINGSanta Monica, California, 90404, United States
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West Virginia University (Including Mobile Clinical Trials Unit)
NOT_YET_RECRUITINGMorgantown, West Virginia, 26506, United States
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Other studies related to the condition(s) this trial covers.
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- Can a daily pill tame Gout's uric acid?
- Can a new drug combo crack Hard-to-Treat gout?
- Can a diabetes drug fight gout? metformin takes on febuxostat
- Can a weekly weight drug quiet gout attacks?
- Gout's crystal clues: could urate deposits flag hidden heart risk?