Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout
This study is currently recruiting participants.
Verified by Ardea Biosciences, Inc., October 2008
Sponsored by: Ardea Biosciences, Inc.
Information provided by: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT00741442
  Purpose

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


Condition Intervention Phase
Hyperuricemia
Drug: RDEA806
Drug: Placebo
Phase II

MedlinePlus related topics: Gout
U.S. FDA Resources
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, Dose Ranging, Efficacy and Safety Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout

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

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: July 2008
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
RDEA806 400 mg qd
Drug: RDEA806
Uricosuric agent for the treatment of gout
3: Experimental
RDEA806 400 mg bid
Drug: RDEA806
Uricosuric agent for the treatment of gout
2: Placebo Comparator
Placebo QD
Drug: Placebo
Matching Placebo.
4: Placebo Comparator
Placebo BID
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:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00741442

Contacts
Contact: Beth Sheedy 858.652.6604 bsheedy@ardeabio.com

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

Responsible Party: Ardea Biosciences, Inc ( Kimberly J. Manhard )
Study ID Numbers: RDEA806-501
Study First Received: August 25, 2008
Last Updated: October 16, 2008
ClinicalTrials.gov Identifier: NCT00741442  
Health Authority: Canada: Health Canada

Study placed in the following topic categories:
Hyperuricemia
Gout

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009