Randomized, Double-Blind, Multicenter, Placebo-Controlled, Safety and Efficacy Study of RDEA594 Versus Placebo in the Treatment of Hyperuricemia in Patients with Gout?Estudio Multicéntrico, Aleatorizado, Doble Ciego, Controlado con Placebo, de Seguridad y Eficacia de RDEA 594 en comparación con Placebo en el Tratamiento de la Hiperuricemia en Pacientes con Gota? - Phase 2 Gout Dose Response Study
- Conditions
- Gout / GotaMedDRA version: 9.1Level: LLTClassification code 10018627Term: Gout
- Registration Number
- EUCTR2009-013055-30-ES
- Lead Sponsor
- Ardea Biosciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 140
1.Subject is male or post-menopausal or surgically sterile female.
2.Subject is 18 - 75 years of age.
3.Subject is hyperuricemic (i.e., screening sUA ?8 mg/dL).
4.Subject meets criteria for the diagnosis of gout as per the American Rheumatism Association (ARA) Criteria for the Classification of Acute Arthritis of Primary Gout.
5.Subject is 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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Subject is classified as an overproducer of urine urate (Cur > 6.0 ml/min/1.73 m2 24- hour urine).
2.Subject who 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).
3.Subject with a history or suspicion of drug abuse.
4.Subject with a documented history of or suspicion of kidney stones.
5.Subject with a history of rheumatoid arthritis or other autoimmune disease.
6.Subject with confirmed (positive serology to HIV1 and HIV 2) or suspected HIV infection.
7.Subject with a positive serology to HCV antibodies (Abs), and/or hepatitis B surface antigen (HBsAg).
8.Subjects with a history of malignancy, except treated non-melanomatous skin cancer or cervical dysplasia.
9.Subject with a 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.
10.Subject with any condition predisposing them to QT prolongation including pathological Q-wave (defined as Q-wave >40 msec or depth > 0.4-0.5 mV).
11.Subject with any use of a concomitant medication that prolong the QT/QTc interval within the 14 days prior to Baseline (Day 0).
12.Subject with a QT interval corrected for heart rate according to Fridericia (QTcF) > 450 msec at Screening or pre-dose at Baseline (Day 0).
13.Subject with uncontrolled hypertension (above 150/95).
14.Subject with inadequate renal function [serum creatinine >1.5 mg/dL or creatinine clearance < 60 mL/min (by Cockroft-Gault formula)].
15.Subject with hemoglobin < 10 g/dL (males) or < 9 g/dL (females).
16.Subject with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 x upper limit of normal (ULN).
17.Subject with gamma glutamyl transferase (GGT) > 3 x ULN.
18.Subject with active peptic ulcer disease requiring treatment.
19.Subject with a history of xanthinuria, active liver disease, or hepatic dysfunction.
20.Subject requires therapy with any other urate-lowering medication, other than the study medication.
21.Subject requires long-term use of salicylates; diuretics; azathioprine; mercaptopurine; theophylline; intravenous colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole; or trimethoprim.
22.Subjects taking medications known as enzyme inducers (see section 3.7 for listing).
23.Subject with a 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).
24.Subject is pregnant or breast feeding.
25.Subject who has received an investigational medication within 4 weeks prior to study medication administration.
26.Subject who previously participated in a clinical study involving RDEA806 or RDEA594.
27.Subject with a known hypersensitivity or allergy to RDEA594 or colchicine or any components in their formulations.
28.Subject with a body mass index (BMI) >40 kg/m2.
29.Subjects taking greater than 1000 mg/day of Vitamin C.
30.Subject with any other medi
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the proportion of subjects whose serum urate (sUA) level is < 6.0 mg/dL after 28 days of dosing by treatment group.;Secondary Objective: To evaluate the proportion of subjects whose sUA levels are <6.0 mg/dL at each weekly study visit. <br>To evaluate the absolute and percent reduction from baseline in sUA levels at each weekly study visit.<br>To evaluate the percentage change in 24-hour urine urate level (excretion) from baseline to Day 28.<br>To evaluate the incidence of gout flares.<br>To evaluate the safety and tolerability of RDEA594 in subjects with gout.;Primary end point(s): To compare the proportion of subjects whose serum urate (sUA) level is < 6.0 mg/dL after 28 days of dosing by treatment group.
- Secondary Outcome Measures
Name Time Method