A Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout

Hyperuricemia Clinical Trial

Official title:

Randomized, Double-Blind, Multicenter,Placebo-Controlled, Dose Ranging, Efficacy and Safety Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00741442
• Other study ID #: RDEA806-501
• Status: Completed
• Phase: Phase 2
• First received: August 25, 2008
• Last updated: January 7, 2014
• Start date: July 2008
• Est. completion date: September 2009

Study information

• Verified date: January 2014
• Source: Ardea Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: September 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperuricemia

Intervention

Drug:
• RDEA806
Uricosuric agent for the treatment of gout
• Placebo
Matching Placebo.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ardea Biosciences, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	To evaluate the absolute and percent reduction from baseline in sUA levels		4 weeks	Yes
Secondary	To evaluate percent change in 24-hour urine uric acid level		4 weeks	Yes