GoutPhase 3NCT01808131
Lesinurad and Allopurinol Combination Extension Study in Gout
A Phase 3 study testing Lesinurad in people with Gout, run by Ardea Biosciences, Inc. at 207 sites in 11 countries.
Trial summary
This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with allopurinol over a long-term timeframe. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gout
- What is being tested?
- Lesinurad
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 717 participants
- Where
- 207 sitesin 11 countries
- Study dates
- Feb 2013to Nov 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study related activity.
- Subject completed the double-blind treatment period in either Study RDEA594-301 or RDEA594-302 and was actively receiving and tolerating study medication (lesinurad or placebo) and allopurinol at the Month 12 visit.
- Subject is male or female; female subjects of childbearing potential must agree to use an effective non-hormonal method of birth
Who cannot join
- Subject has any medical or psychological condition, which in the opinion of the Investigator and/or the 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.
Trial locations and contacts
207 sites in 11 countries.
207 sites in 11 countries
United States151 sites
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Albuquerque, New Mexico, 87106
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Altoona, Pennsylvania, 16602
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Anaheim, California, 92805
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Ann Arbor, Michigan, 48109
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Atlanta, Georgia, 30308
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Atlanta, Georgia, 30328
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Augusta, Georgia, 30909
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Austin, Texas, 78758
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Birmingham, Alabama, 35213
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Birmingham, Alabama, 35235
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Birmingham, Alabama, 35294
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Bountiful, Utah, 84010
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Brandon, Florida, 33511
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Brooklyn, New York, 11201
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Brooksville, Florida, 34601
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Calabash, North Carolina, 28467
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Cedar Rapids, Iowa, 52403
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Charlotte, North Carolina, 28210
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Cincinnati, Ohio, 45224
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Cincinnati, Ohio, 45242
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Clairton, Pennsylvania, 15025
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Cleveland, Ohio, 44122
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Colombus, Ohio, 43235
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Colorado Springs, Colorado, 80918
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Colorado Springs, Colorado, 80922
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Columbia, South Carolina, 29204
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Conyers, Georgia, 30013
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Cumberland, Maryland, 21502
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Dallas, Texas, 75218
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Danville, Virginia, 24541
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Dayton, Ohio, 45417
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Dayton, Ohio, 45424
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Denver, Colorado, 80220
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Duncansville, Pennsylvania, 16635
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Elizabethtown, Kentucky, 42701
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Englewood, Colorado, 80113
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Fargo, North Dakota, 58103
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Flint, Michigan, 48504
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Fort Worth, Texas, 76135
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Franklin, Ohio, 45005
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Glendale, Arizona, 85308
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Gold River, California, 95670
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Greensboro, North Carolina, 27405
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Gulf Shores, Alabama, 36542
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Gurnee, Illinois, 60031
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Hartsdale, New York, 10530
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Hazelwood, Missouri, 63042
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Hickory, North Carolina, 28602
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Honolulu, Hawaii, 96814
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Houston, Texas, 77043
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Houston, Texas, 77062
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Houston, Texas, 77074
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Houston, Texas, 77099
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Idaho Falls, Idaho, 83404
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Indiana, Pennsylvania, 15701
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Irvine, California, 92618
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Irving, Texas, 75061
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Jacksonville, Florida, 32205
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Jefferson City, Missouri, 65109
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Jenkintown, Pennsylvania, 19046
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Johns Creek, Georgia, 30097
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Jupiter, Florida, 33458
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Kalamazoo, Michigan, 49009
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Kansas City, Missouri, 64114
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Kingwood, Texas, 77339
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Knoxville, Tennessee, 37919
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Knoxville, Tennessee, 37923
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Layton, Utah, 84041
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Lexington, Kentucky, 40503
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Little Rock, Arkansas, 72206
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Little Rock, Arkansas, 72211
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Little Rock, Arkansas, 72223
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Manassas, Virginia, 20110
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McMurray, Pennsylvania, 15317
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Memphis, Tennessee, 38119
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Meridian, Idaho, 83642
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Meridian, Idaho, 83646
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Mesa, Arizona, 85203
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Metairie, Louisiana, 70002
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Metairie, Louisiana, 70006
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Miami, Florida, 33125
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Miami, Florida, 33169
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Miami, Florida, 33186
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Middleburg Heights, Ohio, 44130
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Midlothian, Virginia, 23114
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Milwaukee, Wisconsin, 53226
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Morgantown, West Virginia, 26505
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Mt. Pleasant, South Carolina, 29464
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Myrtle Beach, South Carolina, 29588
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Nassau Bay, Texas, 77058
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Natchitoches, Louisiana, 71457
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New York, New York, 10036
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Ocala, Florida, 34474
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Oklahoma City, Oklahoma, 73103
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Olympia, Washington, 98502
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Omaha, Nebraska, 68114
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Paducah, Kentucky, 42003
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Pembroke Pines, Florida, 33027
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Peoria, Arizona, 85381
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Perrysburg, Ohio, 43551
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Pinson, Alabama, 35126
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Pittsburgh, Pennsylvania, 15206
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Plano, Texas, 75024
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Plano, Texas, 75075
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Plant City, Florida, 33563
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Port Orange, Florida, 32127
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Portland, Oregon, 97220
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Raleigh, North Carolina, 27609
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Reno, Nevada, 89502
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Richmond, Virginia, 23219
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Richmond, Virginia, 23233
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Richmond, Virginia, 23235
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Rock Hill, South Carolina, 29732
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Roseville, California, 95661
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Roswell, Georgia, 30075
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Sacramento, California, 95825
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Salt Lake City, Utah, 84102
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San Angelo, Texas, 76904
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San Antonio, Texas, 78209
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San Antonio, Texas, 78215
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San Antonio, Texas, 78229
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San Diego, California, 92108
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San Leandro, California, 94578
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San Ramon, California, 94582
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Savannah, Georgia, 31406
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Scottdale, Pennsylvania, 15683
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Sealy, Texas, 77474
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Seattle, Washington, 98104
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Shelby, North Carolina, 28150
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Shelby, North Carolina, 28152
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Southfield, Michigan, 48034
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Spartanburg, South Carolina, 29303
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Spokane, Washington, 99208
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Spring Hill, Tennessee, 37174
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St Louis, Missouri, 63117
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Sugar Land, Texas, 77479
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Tacoma, Washington, 98405
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Tampa, Florida, 33607
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Tampa, Florida, 33634
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Traverse City, Michigan, 49684
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Tulsa, Oklahoma, 74104
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Union, South Carolina, 29379
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Vero Beach, Florida, 32960
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Virginia Beach, Virginia, 23462
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Waco, Texas, 76710
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Washington, Missouri, 63090
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West Jordan, Utah, 84088
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Willoughby Hills, Ohio, 44094
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Wilmington, North Carolina, 28401
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Winston-Salem, North Carolina, 27103
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Worcester, Massachusetts, 01605
South Africa14 sites
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Durban, 4001
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Muckleneuk, Pretoria, 0002
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Newlands, Durban, 4037
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Newtown, Johannesburg, 2113
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Paarl, 7646
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Parktown, Johannesburg, 2193
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Radiokop, Johannesburg, 1724
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Rondebosch, 7700
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Silverglen, Durban, 4092
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Sowento, Johannesburg, 1804
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Stellenbosch, 7600
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Thabazimbi, Limpopo, 0380
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Witbank, 1035
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Worcester, 6850
New Zealand7 sites
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Beckenham, Christchurch, 8024
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Birkinhead, 0626
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Grafton, Auckland, 1023
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Hamilton, 3204
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Otahuhu, Auckland, 2025
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Rotorua, 3010
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Tauranga, 3143
Canada6 sites
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Coquitlam, British Columbia, V3K 3P4
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Kitchener, Ontario, N2M 5N6
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London, Ontario, N6A 5R8
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Penticton, British Columbia, V2A 5C8
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Québec, Quebec, G1V 3M7
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Toronto, Ontario, M9W4L6
Germany6 sites
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Dresden, Saxony, 01069
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Dresden, Saxony, 01307
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Eichstätt, Bavaria, 85072
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Goch, North Rhine-Westphalia, 47574
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Kamenz, Saxony, 01917
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Leipzig, Saxony, 04109
Poland6 sites
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Gmina Końskie, Świętokrzyskie Voivodeship, 26-200
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Katowice, Silesian Voivodeship, 40-954
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Krakow, Lesser Poland Voivodeship, 30-510
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Poznan, Greater Poland Voivodeship, 60-773
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Warminsko-mazurskie, 82-300
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Warsaw, 01-192
Australia5 sites
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Brisbane, QLD 4152
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Clayton, Victoria, 3168
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Heidelberg West, Victoria, 3081
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Herston, Queensland, 4029
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Woodville South, 5011
Ukraine5 sites
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Kharkiv, 61157
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Kharkiv, 61176
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Kyiv, 01680
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Poltava, 36011
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Vinnytsia, 21018
Belgium4 sites
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Genk, 3600
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Kortrijk, 8500
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Lommel, 3920
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Yvoir, 5530
About this study
Official title: A Long-Term Extension Study of Lesinurad in Combination With Allopurinol for Subjects Completing an Efficacy and Safety Study of Lesinurad and Allopurinol
This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with allopurinol over a long-term timeframe.
Read the detailed description
This is a Phase 3 extension study to assess the long-term efficacy and safety of lesinurad in combination with allopurinol in subjects who completed the double-blind treatment period in Studies RDEA594-301 and RDEA594-302.
- Conditions
- Gout
- Being tested
- Lesinurad
- Keywords
- Gout
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LesinuradDrug
Tablets, 200 mg QD
LesinuradDrug
Tablets, 400 mg QD
| Study group | Role | What they receive |
|---|---|---|
| lesinurad 200 mg + allopurinol | Experimental | Not described Receives: Drug: Lesinurad |
| lesinurad 400 mg + allopurinol | Experimental | Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 4, dated 07 October 2015. Receives: Drug: Lesinurad |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with an sUA level that is < 6.0 mg/dL
Measured: up to a total of 5 years
Secondary outcomes (1)
Resolution of at least 1 target tophi
Measured: Up to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionAug 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 717 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ardea Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nihar Bhakta, MD, Study director, Ardea Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808131
- Sponsor's protocol ID
- RDEA594-306
- Other IDs
- 2012-004389-16
- Status last verified
- Jan 2017
- First submitted
- 7 Mar 2013
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term Extension Study of Lesinurad in Combination With Allopurinol for Subjects Completing an Efficacy and Safety Study of Lesinurad and Allopurinol
- ClinicalTrials.gov ID
- NCT01808131
- Acronym / sponsor ID
- RDEA594-306
- Conditions
- Gout
- Keywords
- Gout
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 717 participants (actual)
- Lead sponsor
- Ardea Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 11 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with allopurinol over a long-term timeframe.
Detailed description
This is a Phase 3 extension study to assess the long-term efficacy and safety of lesinurad in combination with allopurinol in subjects who completed the double-blind treatment period in Studies RDEA594-301 and RDEA594-302.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lesinurad 200 mg + allopurinol | Experimental | Drug: Lesinurad |
| lesinurad 400 mg + allopurinol | Experimental | Drug: LesinuradPatients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 4, dated 07 October 2015. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study related activity.
- Subject completed the double-blind treatment period in either Study RDEA594-301 or RDEA594-302 and was actively receiving and tolerating study medication (lesinurad or placebo) and allopurinol at the Month 12 visit.
- Subject is male or female; female subjects of childbearing potential must agree to use an effective non-hormonal method of birth
Key exclusion criteria (1 listed)
- Subject has any medical or psychological condition, which in the opinion of the Investigator and/or the 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LesinuradTablets, 200 mg QD | Drug | lesinurad 200 mg + allopurinol |
| LesinuradTablets, 400 mg QD | Drug | lesinurad 400 mg + allopurinol |
Primary outcome
Proportion of subjects with an sUA level that is < 6.0 mg/dL
Time frame: up to a total of 5 years
1 secondary outcome
Resolution of at least 1 target tophi
Time frame: Up to Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
Related trials for Gout
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Gout
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Tophaceous Gout
Tophaceous Gout
Not yet recruitingPhase 3
Combined Metabolic Activator Supplementation in Subjects Diagnosed With Gout
Gout Disease
Enrolling by invitation
The Remote Monitoring of Gout Study
Gout Initiating Urate-loweringUrate-lowering Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nihar Bhakta, MD study director
Ardea Biosciences, Inc.
207 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lesinurad in people with Gout, run by Ardea Biosciences, Inc. at 207 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 207 sites in United States, South Africa, New Zealand, Canada, Germany and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with an sUA level that is < 6.0 mg/dL (time frame: up to a total of 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2017.