Phase 4 Gout Trial, Completed NCT01391325 Sponsor: Ardea Biosciences, Inc. Condition: Gout
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,732 people, all of whom received allopurinol, a medication commonly used to lower uric acid levels in people with gout. Of those who started, 1,238 completed the study and 494 did not finish. The trial was primarily set up to look at how often participants experienced unwanted side effects (called "treatment emergent adverse events") while taking the medication. It also tracked uric acid levels in the blood, how often gout flares occurred, and changes in participants' quality of life over six months. The reported data shows that 55.1% of participants experienced at least one unwanted side effect during the study period. For the secondary measurements, 43.4% of participants had their blood uric acid level fall below 6.0 mg/dL (a commonly used target level) at the six-month mark. The reported data also shows that 33.4% of participants experienced at least one gout flare that needed treatment during the study. Regarding quality of life, participants completed a standard survey (called the SF-36) that measures physical and mental wellbeing on a scale where higher scores mean less difficulty. The reported data shows an average improvement of 3.88 points in the physical score and 0.71 points in the mental score from the start of the study to six months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 4 Gout Trial, Completed

NCT01391325
Completed Phase 4 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with gout according to a specific set of recognised medical guidelines.
  • If you are not currently taking medication to lower uric acid, your uric acid blood level must be 8.0 mg/dL or higher at the screening appointment.
  • If you are currently taking medication to lower uric acid, your uric acid blood level must be 6.5 mg/dL or higher at the screening appointment.
  • You have had at least 2 gout flare-ups (painful attacks) in the past year.

Who may not be able to join:

  • You drink more than 14 alcoholic drinks per week (where one drink counts as a small glass of wine, a can of beer, or a shot of spirits).
  • You have a history of, or are suspected to have, a problem with drug misuse.
  • You have an autoimmune disease that requires ongoing medication to treat it.
  • You are known or suspected to have HIV, hepatitis C, or hepatitis B infection.
  • You have been diagnosed with cancer in the last 5 years (with some exceptions for certain minor skin or cervical conditions that have been fully treated — confirm with trial site).
  • You have had a heart attack, severe heart failure, unstable chest pain, or a stroke within the last 12 months.
  • You have high blood pressure that is not well controlled (above certain levels set by the trial).
  • Your kidneys are not working well enough, based on a specific calculation using a blood test result.
  • You have had a kidney or other organ transplant.
  • You currently have an active stomach ulcer that requires treatment.
  • You have a condition called xanthinuria, or you have active liver disease or poor liver function.
  • You are unable to take standard gout prevention medication (such as colchicine or anti-inflammatory painkillers) due to health reasons or interactions with other medicines you take.
  • You are known to be allergic or sensitive to the medicine allopurinol.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: S Baumgartner, MD, Ardea Biosciences, Inc.

Australian sites

, Camperdown, New South Wales
, Wollongong, New South Wales
, Birsbane, Queensland
, Daw Park, South Australia
, Woodville South, South Australia
, Hobart, Tasmania
, Clayton, Victoria
, Heidelberg, Victoria
, North Ballarat, Victoria
, Perth, Western Australia
, Malvern East,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Completed
Phase
Phase 4
Sponsor
Ardea Biosciences, Inc.
Registry
ClinicalTrials.gov
Start date
1 July 2011
Est. completion
1 January 2013

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇨🇦 Canada 🇩🇪 Germany 🇳🇿 New Zealand 🇿🇦 South Africa 🇺🇸 United States

11 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Safety of Allopurinol

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov