DECT Study in Allopurinol-Treated Gout Patients

Completed

Conditions studied: Gout

In brief

The purpose of this study is to determine presence and volume of monosodium urate (MSU) crystal deposits as determined by dual-energy computed tomography (DECT) imaging in gout subjects treated with allopurinol with and without visible tophi.

Key facts

Study ID

NCT02393560

Run by

Ardea Biosciences, Inc.

People needed

223

Starts

2015-04-01

Expected to finish

2016-10-01

Last updated by the study team

2017-01-25

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is able to understand the study procedures, the risks involved and willing to provide written informed consent before the first study related activity.
• Subject is willing to adhere to the visit/protocol schedules.
• Subject meets the diagnosis of gout as per the American Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary Gout.
• Subject has been taking allopurinol at a dose of at least 300 mg daily for at least 12 weeks prior to Day 1, as the sole uratelowering therapy.

You may not qualify if…

• Subject who is pregnant or breastfeeding.
• Subject with any other medical or psychological condition, which in the opinion of the Investigator and/or Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements (including dual energy computed tomography imaging), or to complete the study.
• Subject who has received an investigational therapy or has participated in any clinical trial or research study within 30 days of Day 1.
• Subject who has taken pegloticase (KRYSTEXXA®) or is expected to take pegloticase during the study.

Where it is running

• Study site — Irvine, California, United States
• Study site — Englewood, Colorado, United States
• Study site — Wheat Ridge, Colorado, United States
• Study site — Atlanta, Georgia, United States
• Study site — Cleveland, Ohio, United States
• Study site — Lyndhurst, Ohio, United States
• Study site — Willoughby Hills, Ohio, United States
• Study site — Dallas, Texas, United States
• Study site — Plano, Texas, United States
• Study site — Grafton, Auckland, New Zealand

Full record on ClinicalTrials.gov

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