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
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

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 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 ]

Enrollment: 3
Study Start Date: July 2008
Study Completion Date: September 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00741442

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

No publications provided

Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT00741442     History of Changes
Other Study ID Numbers: RDEA806-501
Study First Received: August 25, 2008
Last Updated: January 7, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Hyperuricemia
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014