Allopurinol Combination Study

Completed · Phase 2 · Has a placebo group

Conditions studied: Gout

In brief

To compare the proportion of subjects whose serum urate (sUA) levels are \< 6.0 mg/dL following 4 weeks of continuous treatment of RDEA594 in combination with allopurinol to allopurinol alone in subjects with documented inadequate hypouricemic response with standard doses of allopurinol.

Key facts

Study ID

NCT01001338

Run by

Ardea Biosciences, Inc.

People needed

227

Starts

2009-10-01

Expected to finish

2016-08-01

Last updated by the study team

2017-01-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or a post-menopausal or surgically sterile female.
• 18 - 80 years of age.
• Has been taking allopurinol as the sole urate lowering therapy for hyperuricemia for at least 6 weeks at a dose between 200 mg and 600 mg per day without an adequate response.
• Has a sUA level ≥ 6 mg/dL at screening.
• 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 completed 28 days of dosing in the Double-Blind Treatment Period and the Day 42 Visit in the Follow-up Period within 4 months and must not have experienced any serious adverse events considered possibly related to study drug.
• Subjects entering the optional Open-Label Extension Period must continue to be compliant with the protocol through Week 44 of the Double-Blind Extension Period and must not have experienced any serious adverse events considered possibly related to study drug.

You may not qualify if…

• 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.
• History of documented or suspected kidney stones.
• Has rheumatoid arthritis or other autoimmune disease requiring treatment.
• Documented or suspicion of HIV infection.
• Positive serology to HCV antibodies (Abs), and/or hepatitis B surface antigen (HBsAg).
• History of malignancy within 5 years prior to the first dose of study medication, other than non-melanomatous skin cancer or cervical dysplasia.
• History of cardiac abnormalities, including abnormal and clinically relevant ECG changes
• Any condition predisposing to QT prolongation including pathological Q-wave (defined as Q-wave >40 msec or depth > 0.4-0.5 mV).
• Any use of concomitant medications that prolong the QT/QTc interval within the 14 days prior to Baseline (Day 1).
• QT interval corrected for heart rate according to Fridericia (QTcF) > 450 msec at Screening or pre-dose at Baseline (Day 1).
• Uncontrolled hypertension (above 150/95).
• Inadequate renal function [serum creatinine >1.5 mg/dL or creatinine clearance < 60 mL/min (by Cockroft-Gault formula)].
• 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 medications.
• Requires long-term use of salicylates; diuretics; losartan; azathioprine; mercaptopurine; theophylline; intravenous colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole; or trimethoprim.
• Taking medications known as enzyme inducers (see section 3.7 for listing).
• Reports receiving a strong or moderate inhibitor of CYP3A4 or a P-gp inhibitor within 1 month prior to study drug dosing, due to potential interactions with colchicine.
• Acute gout flare (exclusive of chronic synovitis/ arthritis) during the Screening-Period that has not resolved one week prior to the Baseline Visit (Day 0).
• Pregnant or breast feeding.
• Has received an investigational medication within 4 weeks prior to the screening visit for this study.

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — La Jolla, California, United States
• Study site — Los Angeles, California, United States
• Study site — Stanford, California, United States
• Study site — Boca Raton, Florida, United States
• Study site — DeLand, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Jupiter, Florida, United States
• Study site — Meridan, Idaho, United States
• Study site — Lexington, Kentucky, United States
• Study site — Wheaton, Maryland, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Reno, Nevada, United States
• Study site — Harrisburg, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Mayfield Village, Ohio, United States
• Study site — Durham, South Carolina, United States
• Study site — Rock Hill, South Carolina, United States
• Study site — Germantown, Tennessee, United States
• Study site — Jackson, Tennessee, United States
• Study site — Dallas, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — West Jordan, Utah, United States
• Study site — Chesapeake, Virginia, United States

Full record on ClinicalTrials.gov

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