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Gout Dose Response Study - NCT00955981-27103(Clinical Trial 422105)



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City:  Winston-Salem
State:  
NC
Zip Code: 27103
Conditions: Hyperuricemia
Purpose: To compare the proportion of subjects whose serum urate (sUA) level is < 6.0 mg/dL after 28 days of dosing by treatment group.
Study summary:
Criteria: Inclusion Criteria: - 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 (see Appendix B). - 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). Exclusion Criteria: - 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 [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 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 (see section 3.7 for listing). - 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). - Pregnant or breast feeding. - Received an investigational medication within 4 weeks prior to study medication administration. - Previously participated in a clinical study involving RDEA806 or RDEA594. - Known hypersensitivity or allergy to RDEA594 or colchicine or any components in their formulations. - Body mass index (BMI) >40 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.
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Data Source: ClinicalTrials.gov
Date Processed: July 21, 2010
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