Clinical trial NCT01927198: RDEA3170 Monotherapy in Subjects With Gout
Official title: A Phase 2, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of RDEA3170 Monotherapy in Subjects With Gout
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gout
Lead sponsor: Ardea Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2013-08-22
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the serum uric acid lowering effects and safety of 3 dose levels of RDEA3170 compared to placebo in subjects with gout.

Detailed description: This monotherapy study is the initial Phase 2 study for RDEA3170 and is designed to compare the safety and efficacy of multiple dose levels of RDEA3170 with placebo when given for up to 24 weeks to subjects with gout. The placebo control for RDEA3170 is included in this study to minimize bias in study assessments and monitoring. Further, to accomplish the goal of understanding the safety profile of RDEA3170, it is important to compare RDEA3170 monotherapy with placebo for at least 24 weeks.

Eligibility criteria: Inclusion Criteria:

* Subject meets the diagnosis of gout per the American Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary Gout.
* Subject has a serum urate level ≥ 6.5 mg/dL and ≤ 10.0 mg/dL during the Screening Period.
* Subject has a body mass index \< 40 kg/m2.

Exclusion Criteria:

* Subject is pregnant or breastfeeding. Subject consumes more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz \[150 mL\] of wine, 12 oz \[360 mL\] of beer, or 1.5 oz \[45 mL\] of hard liquor).
* Subject has a history or suspicion of kidney stones.
* Subject has a history or suspicion of drug abuse within the past 5 years.
* Subject has a history of symptomatic myositis/myopathy or rhabdomyolysis.
* Subject has a known or suspected human immunodeficiency virus infection.
* Subject has a positive test for active hepatitis B or hepatitis C infection.
* Subject has a history of malignancy within the previous 5 years with the exception of non-melanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia, or treated in situ Grade 1 cervical cancer.
* Subject within the last 12 months with: unstable angina, New York Heart Association class III or IV heart failure, myocardial infarction, stroke, or deep venous thrombosis; or subjects currently receiving anticoagulants.
* Subject has a QT interval corrected for heart rate according to Fridericia's formula \> 450 msec during the Screening Period, confirmed by a repeat assessment.
* Subject has uncontrolled hypertension.
* Subject has an estimated creatinine clearance \< 60 mL/min.
* Subject has an alkaline phosphatase \> 2.0 x upper limit of normal during the Screening Period.
* Subject has active liver disease or impaired hepatic function.
* Subject is receiving chronic treatment with more than 325 mg salicylates per day.
* Subject has a medical condition that requires or may require systemic immunosuppressive (eg, chronic low-dose oral prednisone) or immunomodulatory treatment.
* Subject is unable to take colchicine for gout flare prophylaxis.
* Subject is receiving strong or moderate CYP3A inhibitors, p-glycoprotein inhibitors, or digoxin.
* Subject received any strong enzyme- inducing drug or product (eg, rifampin, rifabutin, phenytoin, phenobarbital, St. John's Wort) within 2 months prior to Day 1 or refuses to refrain from taking these medications until the end of the study.
* Subject received an investigational therapy within 30 days or 5 half-lives (whichever is longer) prior to the Screening Period.
* Subject has any other medical or psychological condition, which in the opinion of the Investigator and/or Medical Monitor, 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.

Primary outcomes:
measure: Efficacy of RDEA3170 monotherapy at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Incidence of treatment-emergent adverse events and change from baseline in laboratory values, vital signs, and electrocardiograms
timeFrame: 8 months
measure: Efficacy of RDEA3170 monotherapy at Week 24
timeFrame: Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Gulf Shores
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Glendale
country: United States
state: Arizona
city: Peoria
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: Gold River
country: United States
state: California
city: Irvine
country: United States
state: California
city: San Leandro
country: United States
state: California
city: San Ramon
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Jacksonville
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Winter Haven
country: United States
state: Florida
city: Dunwoody
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Meridian
country: United States
state: Idaho
city: Gurnee
country: United States
state: Illinois
city: Elizabethtown
country: United States
state: Kentucky
city: Lexington
country: United States
state: Kentucky
city: Metairie
country: United States
state: Louisiana
city: Jackson
country: United States
state: Mississippi
city: Reno
country: United States
state: Nevada
city: New York
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: Shelby
country: United States
state: North Carolina
city: Shelby
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Perrysburgh
country: United States
state: Ohio
city: Perrysburg
country: United States
state: Ohio
city: Willoughby Hills
country: United States
state: Ohio
city: Altoona
country: United States
state: Pennsylvania
city: Greenville
country: United States
state: South Carolina
city: Greer
country: United States
state: South Carolina
city: Mount Pleasant
country: United States
state: South Carolina
city: Rock Hill
country: United States
state: South Carolina
city: Spartanburg
country: United States
state: South Carolina
city: Spring Hill
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Bountiful
country: United States
state: Utah
city: Midlothian
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
Study officials:
affiliation: Ardea Biosciences, Inc.
name: J. Hall, MD
role: STUDY_DIRECTOR
References: