A Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT00741442
First received: August 25, 2008
Last updated: January 7, 2014
Last verified: January 2014

August 25, 2008
January 7, 2014
July 2008
April 2009   (final data collection date for primary outcome measure)
To compare the proportion of subjects whose serum uric acid (sUA) level is <6.0 mg/dL following 4 weeks of continuous treatment with RDEA806. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00741442 on ClinicalTrials.gov Archive Site
  • To evaluate the proportion of subjects whose sUA levels are <6.0 mg/dL, <5.0 mg/dL and <4.0 mg/dL, at each visit. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • To evaluate the absolute and percent reduction from baseline in sUA levels [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • To evaluate percent change in 24-hour urine uric acid level [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout
Randomized, Double-Blind, Multicenter,Placebo-Controlled, Dose Ranging, Efficacy and Safety Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout

The purpose of this study is to determine whether RDEA806 is effective in the treatment of hyperuricemia in gout patients.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hyperuricemia
  • Drug: RDEA806
    Uricosuric agent for the treatment of gout
  • Drug: Placebo
    Matching Placebo.
  • Experimental: 1
    RDEA806 400 mg qd
    Intervention: Drug: RDEA806
  • Experimental: 3
    RDEA806 400 mg bid
    Intervention: Drug: RDEA806
  • Placebo Comparator: 2
    Placebo QD
    Intervention: Drug: Placebo
  • Placebo Comparator: 4
    Placebo BID
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3
September 2009
April 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient is hyperuricemic: screening serum uric acid ≥8 mg/dL.
  • Patient meets one or more of the 1977 ARA criteria for the diagnosis of gout.
  • Patient is willing and able to give informed consent and adhere to visit/protocol schedules
  • All female subjects of child-bearing potential must agree to use a barrier method of birth control (e.g. condom, diaphragm or cap).

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, significant cardiac dysfunction.
  • Diabetes Mellitus requiring treatment
  • Confirmed or suspected HIV-1 infection.
  • Malignancy, except treated non-melanomatous skin cancer and cervical dysplasia.
  • Uncontrolled hypertension.
  • Inadequate renal function.
  • Hemoglobin < 8 g/dL (males) or < 7 g/dL (females).
  • ALT, AST , or GGT 2 x ULN
  • Active peptic ulcer disease.
  • Requires long-term use of salicylates; thiazide diuretics; losartan; azathioprine; mercaptopurine; theophylline; IV colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole; trimethoprim.
  • 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.
  • 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.
  • History of cardiac abnormalities including abnormal and clinically relevant ECG changes.
  • Conditions predisposing to QT prolongation.
  • Any use of concomitant medications that prolong the 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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00741442
RDEA806-501
No
Ardea Biosciences, Inc.
Ardea Biosciences, Inc.
Not Provided
Study Director: Vijay Hingorani, MD, PhD, MBA Ardea Biosciences, Inc.
Ardea Biosciences, Inc.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP