A Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout - Full Text View

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:

MedlinePlus related topics: Gout

U.S. FDA Resources

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
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

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

Locations

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:	October 5, 2011
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:

Hyperuricemia
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013