Clinical trial NCT00741442: A Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout
Official title: Randomized, Double-Blind, Multicenter,Placebo-Controlled, Dose Ranging, Efficacy and Safety Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperuricemia
Lead sponsor: Ardea Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2008-08-26
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: 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.
timeFrame: 4 weeks
Secondary outcomes:
measure: 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.
timeFrame: 4 weeks
measure: To evaluate the absolute and percent reduction from baseline in sUA levels
timeFrame: 4 weeks
measure: To evaluate percent change in 24-hour urine uric acid level
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
state: Ontario
Study officials:
affiliation: Ardea Biosciences, Inc.
name: Vijay Hingorani, MD, PhD, MBA
role: STUDY_DIRECTOR
References: