Randomized, Double-Blind, Multicenter, Placebo-Controlled, Dose Ranging, Efficacy and Safety Study of RDEA806 in Hyperuricemic Subjects with Symptomatic Gout - Gout Dose Ranging Efficacy Study

• Conditions: Gout; MedDRA version: 9.1Level: LLTClassification code 10018627Term: Gout

• Registration Number: EUCTR2008-002315-41-BE
• Lead Sponsor: Ardea Biosciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-17
• Last Update Posted: 21 October 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

•Male or female outpatients of either gender, age 18 - 75 yrs of age.
•Patient is hyperuricemic: screening serum uric acid =8 mg/dL.
•Patient meets one or more of the 1977 ACR criteria for the diagnosis of gout.
•Patient 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, including Washout).
•All female subjects of child-bearing potential must agree to use a double barrier method of birth control (e.g. condom, diaphragm or cap).
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

Exclusion Criteria

•Consumes more than 14 drinks of alcohol per week.
•History or suspicion of drug abuse.
•History of kidney stones.
•Rheumatoid arthritis or other autoimmune disease.
•Confirmed or suspected HIV-1 infection
•Malignancy, except treated non-melanomatous skin cancer and cervical dsyplasia
•Significant cardiac dysfunction including congestive heart failure (NYCA Class III or IV); myocardial infarction or ventricular tachyarrhythmia within the last 6 months; major conduction abnormailities unless corrected with a cardiac pacemaker; prolonged QTC (> 460 msec).
•Uncontrolled hypertension (above 150/95).
•Inadequate renal function (serum creatinine >1.5 mg/dL or creatinine clearance < 60 mL/min (by MDRD method).
•Hemoglobin < 8 g/dL (males) or < 7 g/dL (females).
•ALT, AST , or GGT 2 x ULN
•Active peptic ulcer disease requiring treatment.
•Requires therapy with any other urate-lowering drug other than the RDEA806 during the study.
•Requires long-term use of salicylates (other than daily low dose aspirin = 325 mg/day); thiazide diuretics; losartan; azathioprine; mercaptopurine; theophylline; IV colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole; trimethoprim.
•A gout flare at screening that is resolved for less than one week prior to first treatment with study drug (exclusive of chronic synovitis/ arthritis).
•Pregnant or breast feeding.
•Use of an investigational drug within 4 weeks prior to study drug administration.
•Known hypersensitivity or allergy to RDEA806 or colchicine or any components in their formulations.
•Diabetes Mellitus requiring treatment
•Any other medical or psychological condition which, in the opinion of the investigator, 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.
•Patients taking greater than 1000 mg/day of Vitamin C
• History of cardiac abnormalities including abnormal and clinically relevant ECG changes
• Conditions predisposing to QT prolongation
• Any use of concomitant medications that prolong teh QT/QTc interval within 14 days prior to Day 1
• Subjects with a QTcF interval > 450 milliseconds at screening or on Day -1 or at pre-dose (Hour 0) on Day 1.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified