Gout Dose Response Study

NCT00955981 | Completed Phase 2

• 1 other identifier: RDEA594-202
• Study Type: interventional
• Target: 123
• Locations: 7 countries
• Sites: 29

Brief Summary

To compare the proportion of subjects whose serum urate (sUA) level is \< 6.0 mg/dL after 28 days of dosing by treatment group.

Conditions

Hyperuricemia

Outcome Measures

Primary Outcomes (1)

• To compare the proportion of subjects whose serum urate (sUA) level is < 6.0 mg/dL after 28 days of dosing by treatment group.

  28 Days

Secondary Outcomes (6)

• 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 weekly study visit during the Double-Blind Period.

  28 Days

• To evaluate the absolute and percent reduction from baseline in sUA levels at each weekly study visit.

  28 Days and through extension

• To evaluate the percentage change in 24-hour urine urate level (excretion) from baseline to Day 28.

  28 Days and through extension

• To evaluate the incidence of gout flares.

  28 Days and through extension

• To evaluate the safety and tolerability of RDEA594 in subjects with gout.

  28 Days and through extension

Study Arms (4)

RDEA594 200 mg qd for 28 days

EXPERIMENTAL

Drug: RDEA594

RDEA594 200 mg, 400 mg

EXPERIMENTAL

RDEA594 200 mg qd for 7 days followed by 400 mg qd for 21 days

Drug: RDEA594

RDEA594 200 mg, 400 mg and 600 mg

EXPERIMENTAL

RDEA594 200 mg qd for 7 days followed by 400 mg qd for 7 days followed by 600 mg qd for 14 days

Drug: RDEA594

Matching placebo

PLACEBO COMPARATOR

RDEA594 matching placebo qd for 28 days

Drug: Placebo

Interventions

RDEA594 DRUG

Uricosuric agent for the treatment of gout

RDEA594 200 mg qd for 28 days; RDEA594 200 mg, 400 mg; RDEA594 200 mg, 400 mg and 600 mg

Placebo DRUG

Matching placebo

Matching placebo

Eligibility Criteria

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

You may qualify if:

• Male or post-menopausal or surgically sterile female.
• years of age.
• Hyperuricemic (i.e., screening sUA ≥8 mg/dL).
• Meets criteria for the diagnosis of gout as per the American Rheumatism Association (ARA) Criteria for the Classification of Acute Arthritis of Primary Gout.
• Willing and able to give informed consent and adhere to visit/protocol schedules (informed consent must be given before the first study procedure is performed).
• Subjects entering the optional Extension Period must have successfully completed the Double-Blind Treatment Period and Follow-up Period within approximately 4 months and must not have experienced any serious adverse events considered possibly related to study drug.

You may not qualify if:

• Classified as an overproducer of urine urate (Cur \> 6.0 ml/min/1.73 m2 24- hour urine).
• Consumes more than 14 drinks of alcohol per week (e.g., 1 drink = 5 oz \[150 ml\] of wine, 12 oz \[360 ml\] of beer, or 1.5 oz \[45 ml\] of hard liquor).
• History or suspicion of drug abuse.
• Documented history of or suspicion of kidney stones.
• History of rheumatoid arthritis or other autoimmune disease.
• Confirmed (positive serology to HIV1 and HIV 2) or suspected HIV infection.
• Positive serology to HCV antibodies (Abs), and/or hepatitis B surface antigen (HBsAg).
• History of malignancy, except treated non-melanomatous skin cancer or cervical dysplasia.
• History of cardiac abnormalities, including abnormal and clinically relevant ECG changes such as bradycardia (sinus rate \<45 bpm), complete left bundle branch block (LBBB), second or third degree heart block, intraventricular conduction delay with QRS duration \>120 msec, symptomatic or asymptomatic arrhythmias with the exception of sinus arrhythmia, evidence of ventricular pre-excitation, frequent palpitations or syncopal episodes, heart failure, hypokalemia, family history of Long QT Syndrome, and/or family history of sudden death in an otherwise healthy individual between the ages of 1 and 30 years.
• Any condition predisposing them to QT prolongation including pathological Q-wave (defined as Q-wave \>40 msec or depth \> 0.4-0.5 mV).
• Any use of a concomitant medication that prolong the QT/QTc interval within the 14 days prior to Baseline (Day 0)
• QT interval corrected for heart rate according to Fridericia (QTcF) \> 450 msec at Screening or pre-dose at Baseline (Day 0)
• Uncontrolled hypertension (above 150/95)
• Inadequate renal function
• Hemoglobin \< 10 g/dL (males) or \< 9 g/dL (females)

Sponsors & Collaborators

• Ardea Biosciences, Inc.: lead

Study Sites (29)

Unknown Facility

Los Angeles, California, 90017, United States

Location

Unknown Facility

DeLand, Florida, 32720, United States

Location

Unknown Facility

Winston-Salem, North Carolina, 27103, United States

Location

Unknown Facility

Jackson, Tennessee, 38305, United States

Location

Unknown Facility

Pleven, 5800, Bulgaria

Location

Unknown Facility

Plovdiv, 4002, Bulgaria

Location

Unknown Facility

Plovidv, 4002, Bulgaria

Location

Unknown Facility

Sofia, 1233, Bulgaria

Location

Unknown Facility

Sofia, 1709, Bulgaria

Location

Unknown Facility

Varna, 9010, Bulgaria

Location

Unknown Facility

Coquitlam, British Columbia, V3K 3P4, Canada

Location

Unknown Facility

Kelowna, British Columbia, V1Y8E7, Canada

Location

Unknown Facility

Thornhill, Ontario, L4J6W6, Canada

Location

Unknown Facility

Toronto, Ontario, M9W 4L6, Canada

Location

Unknown Facility

Mirabel, Quebec, J7J 2K8, Canada

Location

Unknown Facility

Bruntál, 792 01, Czechia

Location

Unknown Facility

Prague, 140 00, Czechia

Location

Unknown Facility

Prague, 148 00, Czechia

Location

Unknown Facility

Tbilisi, 0102, Georgia

Location

Unknown Facility

Tbilisi, 0186, Georgia

Location

Unknown Facility

Goch, 47574, Germany

Location

Unknown Facility

Hamburg, 22143, Germany

Location

Unknown Facility

Nuremberg, 90402, Germany

Location

Unknown Facility

Elblag, 82-300, Poland

Location

Unknown Facility

Lodz, 90-153, Poland

Location

Unknown Facility

Lublin, 20-607, Poland

Location

Unknown Facility

Poznan, 61-289, Poland

Location

Unknown Facility

Radom, 26-610, Poland

Location

Unknown Facility

Wroclaw, 53-025, Poland

Location

MeSH Terms

Conditions

Hyperuricemia

Interventions

lesinurad

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 7, 2009
• First Posted: August 10, 2009
• Study Start: July 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: September 1, 2011
• Last Updated: March 7, 2014

Record last verified: 2014-02

Locations

PL (6); DE (3); CA (5); BU (6); CZ (3); GE (2); US (4)