A Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout

NCT00741442 | Completed Phase 2

• 1 other identifier: RDEA806-501
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hyperuricemia

Outcome Measures

Primary Outcomes (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.

  4 weeks

Secondary Outcomes (3)

• 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.

  4 weeks

• To evaluate the absolute and percent reduction from baseline in sUA levels

  4 weeks

• To evaluate percent change in 24-hour urine uric acid level

  4 weeks

Study Arms (4)

1

EXPERIMENTAL

RDEA806 400 mg qd

Drug: RDEA806

3

EXPERIMENTAL

RDEA806 400 mg bid

Drug: RDEA806

2

PLACEBO COMPARATOR

Placebo QD

Drug: Placebo

4

PLACEBO COMPARATOR

Placebo BID

Drug: Placebo

Interventions

RDEA806 DRUG

Uricosuric agent for the treatment of gout

1; 3

Placebo DRUG

Matching Placebo.

2; 4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ardea Biosciences, Inc.: lead

Study Sites (1)

Unknown Facility

Toronto, Ontario, M9W 4L6, Canada

Location

MeSH Terms

Conditions

Hyperuricemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vijay Hingorani, MD, PhD, MBA

  Ardea Biosciences, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2008
• First Posted: August 26, 2008
• Study Start: July 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: September 1, 2009
• Last Updated: February 6, 2014

Record last verified: 2014-01

Locations

CA (1)