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Gout Dose Response Study
This study is currently recruiting participants.
Verified by Ardea Biosciences, Inc., August 2009
First Received: August 7, 2009   Last Updated: August 21, 2009   History of Changes
Sponsored by: Ardea Biosciences, Inc.
Information provided by: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT00955981
  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.


Condition Intervention Phase
Hyperuricemia
Drug: RDEA594
Drug: Placebo
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Randomized, Double-Blind, Multicenter, Placebo-Controlled, Safety and Efficacy Study of RDEA594 Versus Placebo in the Treatment of Hyperuricemia in Patients With Gout

Resource links provided by NLM:


Further study details as provided by Ardea Biosciences, Inc.:

Primary Outcome Measures:
  • To compare the proportion of subjects whose serum urate (sUA) level is < 6.0 mg/dL after 28 days of dosing by treatment group. [ Time Frame: 28 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the proportion of subjects whose sUA levels are <6.0 mg/dL at each weekly study visit. [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • To evaluate the absolute and percent reduction from baseline in sUA levels at each weekly study visit. [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • To evaluate the percentage change in 24-hour urine urate level (excretion) from baseline to Day 28. [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • To evaluate the incidence of gout flares. [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • To evaluate the safety and tolerability of RDEA594 in subjects with gout. [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 140
Study Start Date: July 2009
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
RDEA594 200 mg qd for 28 days: Experimental Drug: RDEA594
Uricosuric agent for the treatment of gout
RDEA594 200 mg, 400 mg: Experimental
RDEA594 200 mg qd for 7 days followed by 400 mg qd for 21 days
Drug: RDEA594
Uricosuric agent for the treatment of gout
RDEA594 200 mg, 400 mg and 600 mg: Experimental
RDEA594 200 mg qd for 7 days followed by 400 mg qd for 7 days followed by 600 mg qd for 14 days
Drug: RDEA594
Uricosuric agent for the treatment of gout
Matching placebo: Placebo Comparator
RDEA594 matching placebo qd for 28 days
Drug: Placebo
Matching placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00955981

Contacts
Contact: Jody Welp 858.652.6641 jwelp@ardeabio.com

Locations
Canada, British Columbia
Recruiting
Coquitlam, British Columbia, Canada, V3K 3P4
Recruiting
Kelowna, British Columbia, Canada, V1Y8E7
Canada, Manitoba
Recruiting
Winnipeg, Manitoba, Canada, R3A1M3
Canada, Ontario
Recruiting
Toronto, Ontario, Canada, M9W 4L6
Recruiting
Thornhill, Ontario, Canada, L4J6W6
Canada, Quebec
Recruiting
Mirabel, Quebec, Canada, J7J 2K8
Georgia
Recruiting
Tbilisi, Georgia, 0186
Recruiting
Tbilisi, Georgia, 0102
Sponsors and Collaborators
Ardea Biosciences, Inc.
  More Information

No publications provided

Responsible Party: Ardea Biosciences, Inc. ( Kimberly J. Manhard )
Study ID Numbers: RDEA594-202
Study First Received: August 7, 2009
Last Updated: August 21, 2009
ClinicalTrials.gov Identifier: NCT00955981     History of Changes
Health Authority: Canada: Health Canada;   Georgia: Ministry of Health

Study placed in the following topic categories:
Hyperuricemia
Gout

Additional relevant MeSH terms:
Pathologic Processes
Hyperuricemia

ClinicalTrials.gov processed this record on September 11, 2009