A Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00741442
Recruitment Status : Completed
First Posted : August 26, 2008
Last Update Posted : February 6, 2014
Information provided by (Responsible Party):
Ardea Biosciences, Inc.

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

Condition or disease Intervention/treatment Phase
Hyperuricemia Drug: RDEA806 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Multicenter,Placebo-Controlled, Dose Ranging, Efficacy and Safety Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout
Study Start Date : July 2008
Primary Completion Date : April 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gout
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
RDEA806 400 mg qd
Drug: RDEA806
Uricosuric agent for the treatment of gout
Experimental: 3
RDEA806 400 mg bid
Drug: RDEA806
Uricosuric agent for the treatment of gout
Placebo Comparator: 2
Placebo QD
Drug: Placebo
Matching Placebo.
Placebo Comparator: 4
Placebo BID
Drug: Placebo
Matching Placebo.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. To evaluate the absolute and percent reduction from baseline in sUA levels [ Time Frame: 4 weeks ]
  3. To evaluate percent change in 24-hour urine uric acid level [ Time Frame: 4 weeks ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00741442

Canada, Ontario
Toronto, Ontario, Canada, M9W 4L6
Sponsors and Collaborators
Ardea Biosciences, Inc.
Study Director: Vijay Hingorani, MD, PhD, MBA Ardea Biosciences, Inc.

Responsible Party: Ardea Biosciences, Inc. Identifier: NCT00741442     History of Changes
Other Study ID Numbers: RDEA806-501
First Posted: August 26, 2008    Key Record Dates
Last Update Posted: February 6, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Pathologic Processes