Status:
COMPLETED
Allopurinol Combination Study
Lead Sponsor:
Ardea Biosciences, Inc.
Conditions:
Gout
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 subje...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Previously participated in a clinical study involving RDEA806 or RDEA594.
- Known hypersensitivity or allergy to RDEA594, allopurinol or colchicine or any components in their formulations.
- Body mass index (BMI) \>48 kg/m2.
- Taking greater than 1000 mg/day of Vitamin C.
- 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, or to complete the study.
- Inadequate renal function after completing the Double-Blind Treatment period prior to entering Double-Blind Extension Period.
- Requiring treatment with prohibited medications noted in exclusion criteria numbers 20-23 after completing the Double-Blind Treatment Period prior to entering the Extension Period.
- Clinically relevant medical event as determined by the investigator in consultation with medical monitor prior to entering the Extension Period.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
227 Patients enrolled
Trial Details
Trial ID
NCT01001338
Start Date
October 1 2009
End Date
August 1 2016
Last Update
January 24 2017
Active Locations (44)
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1
Phoenix, Arizona, United States, 85050
2
La Jolla, California, United States, 92037
3
Los Angeles, California, United States, 90017
4
Stanford, California, United States, 94305