A Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout

NCT ID: NCT00741442

Last Updated: 2014-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2009-09-30

Brief Summary

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

Conditions

Hyperuricemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

RDEA806 400 mg qd

Group Type: EXPERIMENTAL

RDEA806

Intervention Type: DRUG

Uricosuric agent for the treatment of gout

3

RDEA806 400 mg bid

Group Type: EXPERIMENTAL

RDEA806

Intervention Type: DRUG

Uricosuric agent for the treatment of gout

2

Placebo QD

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching Placebo.

4

Placebo BID

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching Placebo.

Interventions

RDEA806

Uricosuric agent for the treatment of gout

Intervention Type: DRUG

Placebo

Matching Placebo.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ardea Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vijay Hingorani, MD, PhD, MBA

Role: STUDY_DIRECTOR

Ardea Biosciences, Inc.

Locations

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

RDEA806-501

Identifier Type: -

Identifier Source: org_study_id