Gout Dose Response Study

Completed · Phase 2 · Has a placebo group

Conditions studied: Hyperuricemia

In brief

To compare the proportion of subjects whose serum urate (sUA) level is \< 6.0 mg/dL after 28 days of dosing by treatment group.

Key facts

Study ID

NCT00955981

Run by

Ardea Biosciences, Inc.

People needed

123

Starts

2009-07-01

Expected to finish

2011-09-01

Last updated by the study team

2014-03-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or post-menopausal or surgically sterile female.
• 18 - 75 years of age.
• Hyperuricemic (i.e., screening sUA ≥8 mg/dL).
• Meets criteria for the diagnosis of gout as per the American Rheumatism Association (ARA) Criteria for the Classification of Acute Arthritis of Primary Gout.
• Willing and able to give informed consent and adhere to visit/protocol schedules (informed consent must be given before the first study procedure is performed).
• Subjects entering the optional Extension Period must have successfully completed the Double-Blind Treatment Period and Follow-up Period within approximately 4 months and must not have experienced any serious adverse events considered possibly related to study drug.

You may not qualify if…

• Classified as an overproducer of urine urate (Cur > 6.0 ml/min/1.73 m2 24- hour urine).
• Consumes more than 14 drinks of alcohol per week (e.g., 1 drink = 5 oz [150 ml] of wine, 12 oz [360 ml] of beer, or 1.5 oz [45 ml] of hard liquor).
• History or suspicion of drug abuse.
• Documented history of or suspicion of kidney stones.
• History of rheumatoid arthritis or other autoimmune disease.
• Confirmed (positive serology to HIV1 and HIV 2) or suspected HIV infection.
• Positive serology to HCV antibodies (Abs), and/or hepatitis B surface antigen (HBsAg).
• History of malignancy, except treated non-melanomatous skin cancer or cervical dysplasia.
• History of cardiac abnormalities, including abnormal and clinically relevant ECG changes such as bradycardia (sinus rate <45 bpm), complete left bundle branch block (LBBB), second or third degree heart block, intraventricular conduction delay with QRS duration >120 msec, symptomatic or asymptomatic arrhythmias with the exception of sinus arrhythmia, evidence of ventricular pre-excitation, frequent palpitations or syncopal episodes, heart failure, hypokalemia, family history of Long QT Syndrome, and/or family history of sudden death in an otherwise healthy individual between the ages of 1 and 30 years.
• Any condition predisposing them to QT prolongation including pathological Q-wave (defined as Q-wave >40 msec or depth > 0.4-0.5 mV).
• Any use of a concomitant medication that prolong the QT/QTc interval within the 14 days prior to Baseline (Day 0)
• QT interval corrected for heart rate according to Fridericia (QTcF) > 450 msec at Screening or pre-dose at Baseline (Day 0)
• Uncontrolled hypertension (above 150/95)
• Inadequate renal function
• Hemoglobin < 10 g/dL (males) or < 9 g/dL (females)
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 x upper limit of normal (ULN)
• Gamma glutamyl transferase (GGT) > 3 x ULN
• Active peptic ulcer disease requiring treatment
• History of xanthinuria, active liver disease, or hepatic dysfunction.
• Requires therapy with any other urate-lowering medication, other than the study medication.
• Requires long-term use of salicylates; diuretics; azathioprine; mercaptopurine; theophylline; intravenous colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole; or trimethoprim
• Taking medications known as enzyme inducers
• Receiving a strong or moderate inhibitor of CYP3A4 or a P-gp inhibitor within 1 month prior to study drug dosing
• Gout flare at screening that is resolved for less than one week prior to the first treatment with study medication (exclusive of chronic synovitis/ arthritis)
• Female of childbearing potential

Where it is running

• Study site — Los Angeles, California, United States
• Study site — DeLand, Florida, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Jackson, Tennessee, United States
• Study site — Pleven, Bulgaria
• Study site — Plovdiv, Bulgaria
• Study site — Plovidv, Bulgaria
• Study site — Sofia, Bulgaria
• Study site — Sofia, Bulgaria
• Study site — Varna, Bulgaria
• Study site — Coquitlam, British Columbia, Canada
• Study site — Kelowna, British Columbia, Canada
• Study site — Thornhill, Ontario, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Mirabel, Quebec, Canada
• Study site — Bruntál, Czechia
• Study site — Prague, Czechia
• Study site — Prague, Czechia
• Study site — Tbilisi, Georgia
• Study site — Tbilisi, Georgia
• Study site — Goch, Germany
• Study site — Hamburg, Germany
• Study site — Nuremberg, Germany
• Study site — Elblag, Poland
• Study site — Lodz, Poland

Full record on ClinicalTrials.gov

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