Trial record 1 of 1 for:    NCT00955981
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Gout Dose Response Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00955981
Recruitment Status : Completed
First Posted : August 10, 2009
Last Update Posted : March 7, 2014
Information provided by (Responsible Party):
Ardea Biosciences, Inc.

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.

Condition or disease Intervention/treatment Phase
Hyperuricemia Drug: RDEA594 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Multicenter, Placebo-Controlled, Safety and Efficacy Study of RDEA594 Versus Placebo in the Treatment of Hyperuricemia in Patients With Gout
Study Start Date : July 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
MedlinePlus related topics: Gout
Drug Information available for: Lesinurad

Arm Intervention/treatment
Experimental: RDEA594 200 mg qd for 28 days Drug: RDEA594
Uricosuric agent for the treatment of gout

Experimental: RDEA594 200 mg, 400 mg
RDEA594 200 mg qd for 7 days followed by 400 mg qd for 21 days
Drug: RDEA594
Uricosuric agent for the treatment of gout

Experimental: RDEA594 200 mg, 400 mg and 600 mg
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
Uricosuric agent for the treatment of gout

Placebo Comparator: Matching placebo
RDEA594 matching placebo qd for 28 days
Drug: Placebo
Matching placebo

Primary Outcome Measures :
  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. [ Time Frame: 28 Days ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 28 Days ]
  2. To evaluate the absolute and percent reduction from baseline in sUA levels at each weekly study visit. [ Time Frame: 28 Days and through extension ]
  3. To evaluate the percentage change in 24-hour urine urate level (excretion) from baseline to Day 28. [ Time Frame: 28 Days and through extension ]
  4. To evaluate the incidence of gout flares. [ Time Frame: 28 Days and through extension ]
  5. To evaluate the safety and tolerability of RDEA594 in subjects with gout. [ Time Frame: 28 Days and through extension ]
  6. To evaluate the proportion of subjects whose sUA level decreases to or is maintained at <6.0 mg/dL in the Open-Label Extension Period. [ Time Frame: 18 Months ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or post-menopausal or surgically sterile female.
  • 18 - 75 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.

Exclusion Criteria:

  • 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)
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 x upper limit of normal (ULN)
  • Gamma glutamyl transferase (GGT) > 3 x ULN
  • Active peptic ulcer disease requiring treatment
  • History of xanthinuria, active liver disease, or hepatic dysfunction.
  • Requires therapy with any other urate-lowering medication, other than the study medication.
  • Requires long-term use of salicylates; diuretics; azathioprine; mercaptopurine; theophylline; intravenous colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole; or trimethoprim
  • Taking medications known as enzyme inducers
  • Receiving a strong or moderate inhibitor of CYP3A4 or a P-gp inhibitor within 1 month prior to study drug dosing
  • Gout flare at screening that is resolved for less than one week prior to the first treatment with study medication (exclusive of chronic synovitis/ arthritis)
  • Female of childbearing potential
  • Received an investigational medication within 4 weeks prior to study medication administration
  • Previously participated in a clinical study involving RDEA806 or RDEA594.
  • Known hypersensitivity or allergy to RDEA594 or colchicine or any components in their formulations.
  • Body mass index (BMI) >40 kg/m2.
  • Taking greater than 1000 mg/day of Vitamin C.
  • 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.
  • Inadequate renal function after completing the Double-Blind Treatment period prior to entering Extension Period.
  • Requiring treatment with prohibited medications noted in exclusion criteria numbers 20-23 after completing the Double-Blind Treatment Period prior to entering the Extension Period.
  • Clinically relevant medical event as determined by the investigator in consultation with medical monitor prior to entering the Extension Period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00955981

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Sponsors and Collaborators
Ardea Biosciences, Inc.
Study Director: Vijay Hingorani, MD, PhD, MBA Ardea Biosciences, Inc.

Responsible Party: Ardea Biosciences, Inc. Identifier: NCT00955981     History of Changes
Other Study ID Numbers: RDEA594-202
First Posted: August 10, 2009    Key Record Dates
Last Update Posted: March 7, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Pathologic Processes
Uricosuric Agents
Gout Suppressants
Antirheumatic Agents
Renal Agents