Allopurinol Combination Study
- Conditions
- Gout.MedDRA version: 19.0Level: PTClassification code 10018627Term: GoutSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2009-014660-19-PL
- Lead Sponsor
- Ardea Biosciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 211
1.Subject is male or a post-menopausal or surgically sterile female. (Post-menopausal is generally defined as a period of twelve (12) consecutive months of amenorrhoea. In women under 55 years of age whose menopausal status is in question, a follicle-stimulating hormone (FSH) level of >40 mIU/ml or an oestrogen deficiency of < 30 pg/m or a negative oestrogen test can confirm they are post-menopausal.)
2.Subject is 18 - 80 years of age.
3.Subject has been taking allopurinol as the sole urate lowering therapy for hyperuricemia for at least 6 weeks at a dose of 200 - 600 mg per day without an adequate response (i.e., sUA level not less than 6.0 mg/dL on at least 2 occasions at least approximately 2 weeks apart, which can include the screening visit).
4.Subject has a sUA level = 6 mg/dL at screening.
5.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.
6.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).
7.Subjects entering the optional Double-Blind Extension Period must have completed 28 days of dosing (+/- 3 days) 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.
8. 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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 193
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18
1.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).
2.Subject with a history or suspicion of drug abuse.
3.Subject with a history of documented or suspected kidney stones.
4.Subject has a history of rheumatoid arthritis or other autoimmune disease requiring treatment.
5.Subject with documented or suspicion of HIV infection.
6.Subject with a positive serology to HCV antibodies (Abs), and/or hepatitis B surface antigen (HBsAg).
7.Subject with a history of malignancy within 5 years prior to the first dose of study medication, other than non-melanomatous skin cancer or cervical dysplasia.
8.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 otherwise healthy individual between the ages of 1 and 30 years.
9.Subject with any condition predisposing to QT prolongation including pathological Q-wave (defined as Q-wave >40 msec or depth > 0.4-0.5 mV).
10.Subject with any use of concomitant medications that prolong the QT/QTc interval within the 14 days prior to Baseline (Day 1).
11.Subject with a QT interval corrected for heart rate according to Fridericia (QTcF) > 450 msec at Screening or pre-dose at Baseline (Day 1).
12.Subject with uncontrolled hypertension (above 150/95).
13.Subject with inadequate renal function [serum creatinine >1.5 mg/dL or creatinine clearance < 60 mL/min (by Cockroft-Gault formula)].
14.Subject with a hemoglobin < 10 g/dL (males) or < 9 g/dL (females).
15.Subject with an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2.5 x upper limit of normal (ULN).
16.Subject with a gamma glutamyl transferase (GGT) > 3 x ULN.
17.Subject with active peptic ulcer disease requiring treatment.
18.Subject with a history of xanthinuria, active liver disease, or hepatic dysfunction.
19.Subject requires therapy with any other urate-lowering medication, other than the study medications.
20.Subject requires long-term use of salicylates above 100 mg per day; thiazide diuretics (except low-dose hydrochlorothiazide); losartan; azathioprine; mercaptopurine; theophylline; intravenous colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole; or trimethoprim.
21.Subject taking medications known as enzyme inducers.
22.Subject 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.
23.Subject with an 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).
24.Subject is pregnant or breast feeding.
25.Subject who has received an investigational medication within 4 weeks prior to the screening visit for this study.
26.Subject who previously participated in a clinical study involving RDEA806 or RDEA594.
27.Subject with known hypersensitivity or allergy to RDEA594, allopurino
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method