Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1735 participants
INTERVENTIONAL
2011-07-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Allopurinol
Treatment.
Allopurinol
Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label.
Interventions
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Allopurinol
Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label.
Eligibility Criteria
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Inclusion Criteria
* Not on a urate lowering therapy (ULT) must have an sUA level ≥ 8.0 mg/dL at screening.
* If on concomitant ULT must have an sUA level ≥ 6.5 mg/dL at screening.
* Must have had at least 2 gout flares in the past year.
Exclusion Criteria
* History or suspicion of drug abuse.
* History of autoimmune disease requiring systemic treatment.
* Known or suspected human immunodeficiency virus (HIV), hepatitis C antibody (HCV), or hepatitis B antibody (HBsAg) infection.
* History of malignancy within the previous 5 years (with the exception of nonmelanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia or treated in situ Grade 1 cervical cancer).
* Myocardial infarction, unstable angina, New York Heart Association (NYHA) class III or IV heart failure, or stroke within the last 12 months.
* Uncontrolled hypertension (systolic pressure above 160 mm Hg or diastolic pressure above 95 mm Hg).
* Estimated creatinine clearance \< 30 mL/min by Cockcroft-Gault formula.
* Kidney or other organ transplant.
* Active peptic ulcer disease requiring treatment.
* History of xanthinuria, active liver disease, or hepatic dysfunction.
* If unable to take gout flare prophylaxis of either colchicine or nonsteroidal anti-inflammatory drugs (NSAIDs) due to contraindication (e.g. toxicity, renal function, use of contraindicated medications).
* Known hypersensitivity or allergy to allopurinol.
18 Years
85 Years
ALL
No
Sponsors
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Ardea Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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S Baumgartner, MD
Role: STUDY_DIRECTOR
Ardea Biosciences, Inc.
Locations
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Birmingham, Alabama, United States
Birmingham, Alabama, United States
Bringham, Alabama, United States
Calera, Alabama, United States
Huntsville, Alabama, United States
Mobile, Alabama, United States
Chandlers, Arizona, United States
Green Valley, Arizona, United States
Jonesboro, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Little Rock, Arkansas, United States
Anaheim, California, United States
Carmichael, California, United States
Covina, California, United States
Hemet, California, United States
Irvine, California, United States
Los Angeles, California, United States
Mission Viejo, California, United States
Pasadena, California, United States
Sacramento, California, United States
San Diego, California, United States
San Ramon, California, United States
Santa Maria, California, United States
Weslake Village, California, United States
Denver, Colorado, United States
Englewood, Colorado, United States
Danbury, Connecticut, United States
Trumbull, Connecticut, United States
Brandenton, Florida, United States
Brandon, Florida, United States
Brooksville, Florida, United States
East Brandenton, Florida, United States
Fleming Island, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Jupiter, Florida, United States
Miami, Florida, United States
Oldsmar, Florida, United States
Orlando, Florida, United States
Ormond Beach, Florida, United States
Plant City, Florida, United States
Port Orange, Florida, United States
Sanford, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Vero Beach, Florida, United States
Winter Haven, Florida, United States
Zephyrhills, Florida, United States
Atlanta, Georgia, United States
Newnan, Georgia, United States
Honolulu, Hawaii, United States
Meridian, Idaho, United States
Addison, Illinois, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Gurnee, Illinois, United States
Evansville, Indiana, United States
Elizabethtown, Kentucky, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Monroe, Louisiana, United States
Cumberland, Maryland, United States
Frederick, Maryland, United States
Hagerstown, Maryland, United States
Wheaton, Maryland, United States
Hyannis, Massachusetts, United States
Worcester, Massachusetts, United States
South Traverse City, Michigan, United States
Rochester, Minnesota, United States
Olive Branch, Mississippi, United States
Florissant, Missouri, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Reno, Nevada, United States
Nashua, New Hampshire, United States
Albuquerque, New Mexico, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
Endwell, New York, United States
Hartsdale, New York, United States
Charlotte, North Carolina, United States
Harrisburg, North Carolina, United States
Hickory, North Carolina, United States
Raleigh, North Carolina, United States
Raleigh, North Carolina, United States
Wilmington, North Carolina, United States
Fargo, North Dakota, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Middleburg Heights, Ohio, United States
Oklahoma City, Oklahoma, United States
Eugene, Oregon, United States
Portland, Oregon, United States
Altoona, Pennsylvania, United States
Duncansville, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Charleston, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Spartanburg, South Carolina, United States
Jackson, Tennessee, United States
Spring Hill, Tennessee, United States
Dallas, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Irving, Texas, United States
Mesquite, Texas, United States
San Antonio, Texas, United States
Sugar Land, Texas, United States
Bountiful, Utah, United States
West Jordan, Utah, United States
Arlington, Virginia, United States
Richmond, Virginia, United States
Port Orchard, Washington, United States
Seattle, Washington, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Morgantown, West Virginia, United States
Camperdown, New South Wales, Australia
Wollongong, New South Wales, Australia
Birsbane, Queensland, Australia
Daw Park, South Australia, Australia
Woodville South, South Australia, Australia
Hobart, Tasmania, Australia
Clayton, Victoria, Australia
Heidelberg, Victoria, Australia
North Ballarat, Victoria, Australia
Perth, Western Australia, Australia
Malvern East, , Australia
Brussels, , Belgium
Gozée, , Belgium
Kortrijk, , Belgium
Mouscron, , Belgium
Yvoir, , Belgium
Coquitlam, British Columbia, Canada
Kelowna, British Columbia, Canada
Penticton, British Columbia, Canada
Ottawa, Ontario, Canada
Thornhill, Ontario, Canada
Toronto, Ontario, Canada
Québec, Quebec, Canada
Altenburg, , Germany
Dresden, , Germany
Eichstätt, , Germany
Christchurch, Canterbury, New Zealand
Auckland, , New Zealand
Hamilton, , New Zealand
Papatoetoe, , New Zealand
Rotorua, , New Zealand
Tauranga, , New Zealand
Bloemfontein, , South Africa
Durban, , South Africa
Durban, , South Africa
Durban, , South Africa
East London, , South Africa
Johannesburg, , South Africa
Johannesburg, , South Africa
Paarl, , South Africa
Pretoria, , South Africa
Pretoria, , South Africa
Rondebosch, , South Africa
Stellenbosch, , South Africa
Thabazimbi, , South Africa
Worcester, , South Africa
Countries
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References
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Topless R, Noorbaloochi S, Merriman TR, Singh JA. Change in serum urate level with urate-lowering therapy initiation associates in the immediate term with patient-reported outcomes in people with gout. Semin Arthritis Rheum. 2022 Oct;56:152057. doi: 10.1016/j.semarthrit.2022.152057. Epub 2022 Jun 29.
Becker MA, Fitz-Patrick D, Choi HK, Dalbeth N, Storgard C, Cravets M, Baumgartner S. An open-label, 6-month study of allopurinol safety in gout: The LASSO study. Semin Arthritis Rheum. 2015 Oct;45(2):174-83. doi: 10.1016/j.semarthrit.2015.05.005. Epub 2015 May 21.
Other Identifiers
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ALLO-401
Identifier Type: -
Identifier Source: org_study_id
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