Study Results
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Basic Information
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COMPLETED
PHASE2
227 participants
INTERVENTIONAL
2009-10-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
TRIPLE
Study Groups
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RDEA594 200 mg qd
RDEA594 200 mg qd plus allopurinol qd
RDEA594
Uricosuric agent for the treatment of gout.
Allopurinol
Allopurinol
RDEA594 200 mg, 400 mg qd
RDEA594 200 mg then 400 mg qd plus allopurinol qd.
Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after protocol amendment 16 dated 07 October 2015.
RDEA594
Uricosuric agent for the treatment of gout.
Allopurinol
Allopurinol
Matching Placebo
RDEA594 matching placebo qd plus allopurinol qd, then allopurinol qd alone in open label period.
Patients on allopurinol qd alone were discontinued after protocol amendment 16 dated 07 October 2015.
Placebo
Matching Placebo
Allopurinol
Allopurinol
RDEA594 600 mg qd
RDEA594 200 mg then 400 mg then 600 mg plus allopurinol qd
Patients on lesinurad 600 mg had their dose changed to lesinurad 200 mg after protocol amendment 16 dated 07 October 2015.
RDEA594
Uricosuric agent for the treatment of gout.
Allopurinol
Allopurinol
Interventions
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RDEA594
Uricosuric agent for the treatment of gout.
Placebo
Matching Placebo
Allopurinol
Allopurinol
Eligibility Criteria
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Inclusion Criteria
2. 18 - 80 years of age.
3. Has been taking allopurinol as the sole urate lowering therapy for hyperuricemia for at least 6 weeks at a dose between 200 mg and 600 mg per day without an adequate response.
4. Has a sUA level ≥ 6 mg/dL at screening.
5. Meets criteria for the diagnosis of gout as per the American Rheumatism Association (ARA) Criteria for the Classification of Acute Arthritis of Primary Gout.
6. 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).
7. Subjects entering the optional Extension Period must have completed 28 days of dosing in the Double-Blind Treatment Period and the Day 42 Visit in the Follow-up Period within 4 months and must not have experienced any serious adverse events considered possibly related to study drug.
8. Subjects entering the optional Open-Label Extension Period must continue to be compliant with the protocol through Week 44 of the Double-Blind Extension Period and must not have experienced any serious adverse events considered possibly related to study drug.
Exclusion Criteria
2. History or suspicion of drug abuse.
3. History of documented or suspected kidney stones.
4. Has rheumatoid arthritis or other autoimmune disease requiring treatment.
5. Documented or suspicion of HIV infection.
6. Positive serology to HCV antibodies (Abs), and/or hepatitis B surface antigen (HBsAg).
7. History of malignancy within 5 years prior to the first dose of study medication, other than non-melanomatous skin cancer or cervical dysplasia.
8. History of cardiac abnormalities, including abnormal and clinically relevant ECG changes
9. Any condition predisposing to QT prolongation including pathological Q-wave (defined as Q-wave \>40 msec or depth \> 0.4-0.5 mV).
10. Any use of concomitant medications that prolong the QT/QTc interval within the 14 days prior to Baseline (Day 1).
11. QT interval corrected for heart rate according to Fridericia (QTcF) \> 450 msec at Screening or pre-dose at Baseline (Day 1).
12. Uncontrolled hypertension (above 150/95).
13. Inadequate renal function \[serum creatinine \>1.5 mg/dL or creatinine clearance \< 60 mL/min (by Cockroft-Gault formula)\].
14. Hemoglobin \< 10 g/dL (males) or \< 9 g/dL (females).
15. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5 x upper limit of normal (ULN).
16. Gamma glutamyl transferase (GGT) \> 3 x ULN.
17. Active peptic ulcer disease requiring treatment.
18. History of xanthinuria, active liver disease, or hepatic dysfunction.
19. Requires therapy with any other urate-lowering medication, other than the study medications.
20. Requires long-term use of salicylates; diuretics; losartan; azathioprine; mercaptopurine; theophylline; intravenous colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole; or trimethoprim.
21. Taking medications known as enzyme inducers (see section 3.7 for listing).
22. Reports receiving a strong or moderate inhibitor of CYP3A4 or a P-gp inhibitor within 1 month prior to study drug dosing, due to potential interactions with colchicine.
23. Acute gout flare (exclusive of chronic synovitis/ arthritis) during the Screening-Period that has not resolved one week prior to the Baseline Visit (Day 0).
24. Pregnant or breast feeding.
25. Has received an investigational medication within 4 weeks prior to the screening visit for this study.
26. Previously participated in a clinical study involving RDEA806 or RDEA594.
27. Known hypersensitivity or allergy to RDEA594, allopurinol or colchicine or any components in their formulations.
28. Body mass index (BMI) \>48 kg/m2.
29. Taking greater than 1000 mg/day of Vitamin C.
30. 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.
31. Inadequate renal function after completing the Double-Blind Treatment period prior to entering Double-Blind Extension Period.
33. Clinically relevant medical event as determined by the investigator in consultation with medical monitor prior to entering the Extension Period.
18 Years
80 Years
ALL
No
Sponsors
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Ardea Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Nihar Bhakta, MD
Role: STUDY_DIRECTOR
Ardea Biosciences, Inc.
Locations
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Phoenix, Arizona, United States
La Jolla, California, United States
Los Angeles, California, United States
Stanford, California, United States
Boca Raton, Florida, United States
DeLand, Florida, United States
Fort Lauderdale, Florida, United States
Jupiter, Florida, United States
Meridan, Idaho, United States
Lexington, Kentucky, United States
Wheaton, Maryland, United States
Las Vegas, Nevada, United States
Reno, Nevada, United States
Harrisburg, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Mayfield Village, Ohio, United States
Durham, South Carolina, United States
Rock Hill, South Carolina, United States
Germantown, Tennessee, United States
Jackson, Tennessee, United States
Dallas, Texas, United States
San Antonio, Texas, United States
West Jordan, Utah, United States
Chesapeake, Virginia, United States
Coquitlam, British Columbia, Canada
Kelowna, British Columbia, Canada
St. John's, Newfoundland and Labrador, Canada
Thornhill, Ontario, Canada
Toronto, Ontario, Canada
Mirabel, Quebec, Canada
Bydgoszcz, , Poland
Elblag, , Poland
Lublin, , Poland
Poznan, , Poland
Radom, , Poland
Torun, , Poland
Bilbao, , Spain
Donetsk, , Ukraine
Kharkiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Vinnytsia, , Ukraine
Blackpool, Lancashire, United Kingdom
Countries
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References
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Perez-Ruiz F, Sundy JS, Miner JN, Cravets M, Storgard C; RDEA594-203 Study Group. Lesinurad in combination with allopurinol: results of a phase 2, randomised, double-blind study in patients with gout with an inadequate response to allopurinol. Ann Rheum Dis. 2016 Jun;75(6):1074-80. doi: 10.1136/annrheumdis-2015-207919. Epub 2016 Jan 7.
Other Identifiers
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RDEA594-203
Identifier Type: -
Identifier Source: org_study_id
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