Allopurinol Combination Study
RDEA594-203
Randomized, Double-Blind, Multicenter, Placebo-Controlled, Combination Study to Evaluate the Safety, Efficacy and Potential Pharmacokinetic Interaction of RDEA594 and Allopurinol in Gout Patients With an Inadequate Hypouricemic Response With Standard Doses of Allopurinol
1 other identifier
interventional
227
6 countries
44
Brief Summary
To compare the proportion of subjects whose serum urate (sUA) levels are \< 6.0 mg/dL following 4 weeks of continuous treatment of RDEA594 in combination with allopurinol to allopurinol alone in subjects with documented inadequate hypouricemic response with standard doses of allopurinol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2009
Longer than P75 for phase_2
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 22, 2009
CompletedFirst Posted
Study publicly available on registry
October 26, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedJanuary 24, 2017
January 1, 2017
1.3 years
October 22, 2009
January 23, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
To compare the percent reduction from baseline in serum urate levels following 4 wks of continuous treatment of RDEA594 in combination with allopurinol to allopurinol alone in subjects with documented inadequate hypouricemic response.
28 days
Secondary Outcomes (7)
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 study visit by treatment group in all subjects and in subjects who have an sUA ≥6 mg/dL at the baseline visit.
28 days and through extension
To evaluate the absolute and percent reduction from baseline in sUA levels at each 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 combination with allopurinol in subjects with gout.
28 days and through extension
- +2 more secondary outcomes
Study Arms (4)
RDEA594 200 mg qd
EXPERIMENTALRDEA594 200 mg qd plus allopurinol qd
RDEA594 200 mg, 400 mg qd
EXPERIMENTALRDEA594 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.
Matching Placebo
PLACEBO COMPARATORRDEA594 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.
RDEA594 600 mg qd
EXPERIMENTALRDEA594 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.
Interventions
Uricosuric agent for the treatment of gout.
Allopurinol
Eligibility Criteria
You may qualify if:
- Male or a post-menopausal or surgically sterile female.
- years of age.
- 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.
- Has a sUA level ≥ 6 mg/dL at screening.
- 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 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.
- 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.
You may not qualify if:
- 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.
- History of documented or suspected kidney stones.
- Has rheumatoid arthritis or other autoimmune disease requiring treatment.
- Documented or suspicion of HIV infection.
- Positive serology to HCV antibodies (Abs), and/or hepatitis B surface antigen (HBsAg).
- History of malignancy within 5 years prior to the first dose of study medication, other than non-melanomatous skin cancer or cervical dysplasia.
- History of cardiac abnormalities, including abnormal and clinically relevant ECG changes
- Any condition predisposing to QT prolongation including pathological Q-wave (defined as Q-wave \>40 msec or depth \> 0.4-0.5 mV).
- Any use of concomitant medications that prolong the QT/QTc interval within the 14 days prior to Baseline (Day 1).
- QT interval corrected for heart rate according to Fridericia (QTcF) \> 450 msec at Screening or pre-dose at Baseline (Day 1).
- Uncontrolled hypertension (above 150/95).
- Inadequate renal function \[serum creatinine \>1.5 mg/dL or creatinine clearance \< 60 mL/min (by Cockroft-Gault formula)\].
- 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).
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Unknown Facility
Phoenix, Arizona, 85050, United States
Unknown Facility
La Jolla, California, 92037, United States
Unknown Facility
Los Angeles, California, 90017, United States
Unknown Facility
Stanford, California, 94305, United States
Unknown Facility
Boca Raton, Florida, 33432, United States
Unknown Facility
DeLand, Florida, 32720, United States
Unknown Facility
Fort Lauderdale, Florida, 33334, United States
Unknown Facility
Jupiter, Florida, 33458, United States
Unknown Facility
Meridan, Idaho, 83642, United States
Unknown Facility
Lexington, Kentucky, 40504, United States
Unknown Facility
Wheaton, Maryland, 20902, United States
Unknown Facility
Las Vegas, Nevada, 89183, United States
Unknown Facility
Reno, Nevada, 89502, United States
Unknown Facility
Harrisburg, North Carolina, 28075, United States
Unknown Facility
Cincinnati, Ohio, 45242, United States
Unknown Facility
Cleveland, Ohio, 44122, United States
Unknown Facility
Mayfield Village, Ohio, 44143, United States
Unknown Facility
Durham, South Carolina, 27710, United States
Unknown Facility
Rock Hill, South Carolina, 29732, United States
Unknown Facility
Germantown, Tennessee, 38138, United States
Unknown Facility
Jackson, Tennessee, 38305, United States
Unknown Facility
Dallas, Texas, 75231, United States
Unknown Facility
San Antonio, Texas, 78221, United States
Unknown Facility
West Jordan, Utah, 84088, United States
Unknown Facility
Chesapeake, Virginia, 23320, United States
Unknown Facility
Coquitlam, British Columbia, V3K 3P4, Canada
Unknown Facility
Kelowna, British Columbia, V1Y8E7, Canada
Unknown Facility
St. John's, Newfoundland and Labrador, A1A 3R5, Canada
Unknown Facility
Thornhill, Ontario, L4J 6W6, Canada
Unknown Facility
Toronto, Ontario, M9W 4L6, Canada
Unknown Facility
Mirabel, Quebec, J7J 2K8, Canada
Unknown Facility
Bydgoszcz, 85-168, Poland
Unknown Facility
Elblag, 82-300, Poland
Unknown Facility
Lublin, 20-607, Poland
Unknown Facility
Poznan, 60-773, Poland
Unknown Facility
Radom, 26-610, Poland
Unknown Facility
Torun, 87-100, Poland
Unknown Facility
Bilbao, 48903, Spain
Unknown Facility
Donetsk, 83045, Ukraine
Unknown Facility
Kharkiv, 61176, Ukraine
Unknown Facility
Kyiv, 01610, Ukraine
Unknown Facility
Kyiv, 02125, Ukraine
Unknown Facility
Vinnytsia, 21081, Ukraine
Unknown Facility
Blackpool, Lancashire, FY4 3AD, United Kingdom
Related Publications (1)
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.
PMID: 26742777DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nihar Bhakta, MD
Ardea Biosciences, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2009
First Posted
October 26, 2009
Study Start
October 1, 2009
Primary Completion
January 1, 2011
Study Completion
August 1, 2016
Last Updated
January 24, 2017
Record last verified: 2017-01