Phase 3 Gout Trial, Completed NCT01508702 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 214 people in total — 107 received lesinurad (400 mg) and 107 received a placebo (a dummy treatment with no active ingredient). The trial was measuring how many participants reached a specific level of uric acid in their blood — uric acid being a substance that builds up in some people and can cause problems in the joints. The target level the trial was tracking was a blood uric acid reading below 6.0 mg/dL (milligrams per decilitre, a standard unit of measurement). Not everyone finished the study: 84 people in the lesinurad group and 94 in the placebo group completed it. The reported data shows that, out of the participants measured for the main outcome, 32 people in the lesinurad 400 mg group reached a blood uric acid level below 6.0 mg/dL, compared with 2 people in the placebo group. No other outcome measures were included in the structured data provided, so further details beyond this primary result were not reported in the data available here. 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 3 Gout Trial, Completed

NCT01508702
Completed Phase 3 🇦🇺 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 are able to understand what the study involves, accept the risks, and are willing to sign a consent form before anything begins.
  • You have been diagnosed with gout according to a recognised set of medical classification guidelines.
  • Your uric acid level in your blood was measured at 6.5 mg/dL or higher at two early visits in the study.
  • You are able to take a preventive medication for gout flares, such as colchicine or an anti-inflammatory painkiller (with or without a stomach-protecting medicine).
  • You have a history — either recorded by a doctor or reported by yourself — of not being able to tolerate, or having a medical reason not to take, either allopurinol or febuxostat (common gout medicines).
  • Your body mass index (a measure of weight relative to height) is below 45.

Who may not be able to join:

  • You are currently taking any other approved medication specifically prescribed to lower uric acid for gout.
  • You have a confirmed or suspected history of kidney stones.
  • You are pregnant or breastfeeding.
  • You drink more than 14 alcoholic drinks per week (for example, one drink equals a small glass of wine, a standard can of beer, or a single shot of spirits).
  • You have a history or suspicion of drug misuse within the past 5 years.
  • You need, or may need, medications that suppress or alter your immune system.
  • You have a known or suspected HIV infection.
  • You have tested positive for an active hepatitis B or hepatitis C infection.
  • You have been diagnosed with cancer in the past 5 years, unless it was a type of non-melanoma skin cancer that was fully treated with no return, or treated cervical cell changes or early-stage cervical cancer.
  • In the past 12 months you have had unstable chest pain, severe heart failure, a heart attack, a stroke, or a blood clot in a vein; or you are currently taking blood-thinning medication.
  • You have high blood pressure that is not well controlled.
  • Your kidneys are not working well enough (confirm with trial site for the specific measurement used).
  • You have an active stomach ulcer that needs treatment.
  • You have active liver disease or your liver is not functioning properly.
  • You regularly take more than 325 mg of aspirin (or similar salicylate medicines) per day.
  • You are currently taking valpromide, progabide, or valproic acid (certain medications used for conditions such as epilepsy).
  • You have taken part in another clinical trial or received an experimental treatment within the past 8 weeks (or longer, depending on the medication involved).
  • You have any other medical or mental health condition that the study doctor believes could put you at risk or prevent you from completing the study.

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 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Chris Storgard, MD, Ardea Biosciences, Inc.

Australian sites

, Butterfield, Queensland
, Hobart, Tasmania
, Tasmania,

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

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
Ardea Biosciences, Inc.
Registry
ClinicalTrials.gov
Start date
1 January 2012
Est. completion
1 October 2013

Where this trial is recruiting

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

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

Primary endpoints

Number of Subjects With an sUA Level That is < 6.0 mg/dL

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