Allopurinol Outcome Study

NCT01391325 | Completed Phase 4 Results

• 1 other identifier: ALLO-401
• Study Type: interventional
• Target: 1,735
• Locations: 7 countries
• Sites: 173

Brief Summary

This is a study of allopurinol in gout patients with hyperuricemia that will evaluate the safety and serum urate (sUA) lowering capability of allopurinol as a urate lowering therapy (ULT) for up to six months. Allopurinol will be dosed according to the local product label, at the discretion of the Investigator, to achieve an optimal, medically appropriate dose for each patient.

Conditions

Gout

Outcome Measures

Primary Outcomes (1)

• Safety of Allopurinol

  Proportion of subjects who experienced at least one Treatment Emergent Adverse Event (TEAE) during the study.

  Every month for 6 months.

Secondary Outcomes (3)

• Proportion of Subjects With Serum Urate (sUA) Less Than 6.0 mg/dL

  Month 6

• Incidence of Gout Flares

  Every month for 6 months.

• Mean Change From Baseline to Month 6 in SF-36 PCS+MCS

  Month 6

Study Arms (1)

Allopurinol

OTHER

Treatment.

Drug: Allopurinol

Interventions

Allopurinol DRUG

Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label.

Allopurinol

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets the diagnosis of gout according to the American Rheumatism Association (ARA) Criteria for the Classification of Acute Arthritis of Primary Gout.
• 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.

You may not qualify if:

• Consumption of more than 14 drinks of alcohol per week (eg, 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 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.

Sponsors & Collaborators

• Ardea Biosciences, Inc.: lead

Study Sites (173)

Unknown Facility

Birmingham, Alabama, 35242, United States

Location

Unknown Facility

Birmingham, Alabama, 35294, United States

Location

Unknown Facility

Bringham, Alabama, 35216, United States

Location

Unknown Facility

Calera, Alabama, 35040, United States

Location

Unknown Facility

Huntsville, Alabama, 35801, United States

Location

Unknown Facility

Mobile, Alabama, 36608, United States

Location

Unknown Facility

Chandlers, Arizona, 85224, United States

Location

Unknown Facility

Green Valley, Arizona, 85614, United States

Location

Unknown Facility

Jonesboro, Arizona, 72401, United States

Location

Unknown Facility

Phoenix, Arizona, 85028, United States

Location

Unknown Facility

Phoenix, Arizona, 85050, United States

Location

Unknown Facility

Tucson, Arizona, 85704, United States

Location

Unknown Facility

Little Rock, Arkansas, 72204, United States

Location

Unknown Facility

Little Rock, Arkansas, 72205, United States

Location

Unknown Facility

Anaheim, California, 92805, United States

Location

Unknown Facility

Carmichael, California, 95608, United States

Location

Unknown Facility

Covina, California, 91723, United States

Location

Unknown Facility

Hemet, California, 92543, United States

Location

Unknown Facility

Irvine, California, 92618, United States

Location

Unknown Facility

Los Angeles, California, 90048, United States

Location

Unknown Facility

Mission Viejo, California, 92691, United States

Location

Unknown Facility

Pasadena, California, 91107, United States

Location

Unknown Facility

Sacramento, California, 95816, United States

Location

Unknown Facility

San Diego, California, 92108, United States

Location

Unknown Facility

San Ramon, California, 94583, United States

Location

Unknown Facility

Santa Maria, California, 93454, United States

Location

Unknown Facility

Weslake Village, California, 91361, United States

Location

Unknown Facility

Denver, Colorado, 80220, United States

Location

Unknown Facility

Englewood, Colorado, 80113, United States

Location

Unknown Facility

Danbury, Connecticut, 06810, United States

Location

Unknown Facility

Trumbull, Connecticut, 06611, United States

Location

Unknown Facility

Brandenton, Florida, 34208, United States

Location

Unknown Facility

Brandon, Florida, 33511, United States

Location

Unknown Facility

Brooksville, Florida, 34601, United States

Location

Unknown Facility

East Brandenton, Florida, 34208, United States

Location

Unknown Facility

Fleming Island, Florida, 32003, United States

Location

Unknown Facility

Jacksonville, Florida, 32205, United States

Location

Unknown Facility

Jacksonville, Florida, 32216, United States

Location

Unknown Facility

Jupiter, Florida, 33458, United States

Location

Unknown Facility

Miami, Florida, 33135, United States

Location

Unknown Facility

Oldsmar, Florida, 34677, United States

Location

Unknown Facility

Orlando, Florida, 32804, United States

Location

Unknown Facility

Ormond Beach, Florida, 32174, United States

Location

Unknown Facility

Plant City, Florida, 33563, United States

Location

Unknown Facility

Port Orange, Florida, 32127, United States

Location

Unknown Facility

Sanford, Florida, 32771, United States

Location

Unknown Facility

St. Petersburg, Florida, 33709, United States

Location

Unknown Facility

Tampa, Florida, 33606, United States

Location

Unknown Facility

Vero Beach, Florida, 32960, United States

Location

Unknown Facility

Winter Haven, Florida, 33880, United States

Location

Unknown Facility

Zephyrhills, Florida, 33542, United States

Location

Unknown Facility

Atlanta, Georgia, 30308, United States

Location

Unknown Facility

Newnan, Georgia, 30265, United States

Location

Unknown Facility

Honolulu, Hawaii, 96814, United States

Location

Unknown Facility

Meridian, Idaho, 83646, United States

Location

Unknown Facility

Addison, Illinois, 60101, United States

Location

Unknown Facility

Chicago, Illinois, 60612, United States

Location

Unknown Facility

Chicago, Illinois, 60637, United States

Location

Unknown Facility

Gurnee, Illinois, 60031, United States

Location

Unknown Facility

Evansville, Indiana, 47713, United States

Location

Unknown Facility

Elizabethtown, Kentucky, 42701, United States

Location

Unknown Facility

Lexington, Kentucky, 40504, United States

Location

Unknown Facility

Louisville, Kentucky, 40213, United States

Location

Unknown Facility

Monroe, Louisiana, 71203, United States

Location

Unknown Facility

Cumberland, Maryland, 21502, United States

Location

Unknown Facility

Frederick, Maryland, 21702, United States

Location

Unknown Facility

Hagerstown, Maryland, 21740, United States

Location

Unknown Facility

Wheaton, Maryland, 20902, United States

Location

Unknown Facility

Hyannis, Massachusetts, 02601, United States

Location

Unknown Facility

Worcester, Massachusetts, 01605, United States

Location

Unknown Facility

South Traverse City, Michigan, 49684, United States

Location

Unknown Facility

Rochester, Minnesota, 55905, United States

Location

Unknown Facility

Olive Branch, Mississippi, 38654, United States

Location

Unknown Facility

Florissant, Missouri, 63031, United States

Location

Unknown Facility

Kansas City, Missouri, 64114, United States

Location

Unknown Facility

St Louis, Missouri, 63117, United States

Location

Unknown Facility

St Louis, Missouri, 63128, United States

Location

Unknown Facility

Omaha, Nebraska, 68114, United States

Location

Unknown Facility

Las Vegas, Nevada, 89119, United States

Location

Unknown Facility

Reno, Nevada, 89502, United States

Location

Unknown Facility

Nashua, New Hampshire, 03060, United States

Location

Unknown Facility

Albuquerque, New Mexico, 87102, United States

Location

Unknown Facility

Albuquerque, New Mexico, 87106, United States

Location

Unknown Facility

Albany, New York, 12206, United States

Location

Unknown Facility

Endwell, New York, 13760, United States

Location

Unknown Facility

Hartsdale, New York, 10530, United States

Location

Unknown Facility

Charlotte, North Carolina, 28210, United States

Location

Unknown Facility

Harrisburg, North Carolina, 28075, United States

Location

Unknown Facility

Hickory, North Carolina, 28602, United States

Location

Unknown Facility

Raleigh, North Carolina, 27609, United States

Location

Unknown Facility

Raleigh, North Carolina, 27612, United States

Location

Unknown Facility

Wilmington, North Carolina, 28401, United States

Location

Unknown Facility

Fargo, North Dakota, 58103, United States

Location

Unknown Facility

Cincinnati, Ohio, 45224, United States

Location

Unknown Facility

Cincinnati, Ohio, 45242, United States

Location

Unknown Facility

Cleveland, Ohio, 44122, United States

Location

Unknown Facility

Columbus, Ohio, 43203, United States

Location

Unknown Facility

Dayton, Ohio, 45417, United States

Location

Unknown Facility

Middleburg Heights, Ohio, 44130, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, 73103, United States

Location

Unknown Facility

Eugene, Oregon, 97402, United States

Location

Unknown Facility

Portland, Oregon, 97220, United States

Location

Unknown Facility

Altoona, Pennsylvania, 16602, United States

Location

Unknown Facility

Duncansville, Pennsylvania, 16635, United States

Location

Unknown Facility

Lancaster, Pennsylvania, 17601, United States

Location

Unknown Facility

Charleston, South Carolina, 29407, United States

Location

Unknown Facility

Mt. Pleasant, South Carolina, 29464, United States

Location

Unknown Facility

Spartanburg, South Carolina, 29303, United States

Location

Unknown Facility

Jackson, Tennessee, 38305, United States

Location

Unknown Facility

Spring Hill, Tennessee, 37174, United States

Location

Unknown Facility

Dallas, Texas, 75216, United States

Location

Unknown Facility

Dallas, Texas, 75235, United States

Location

Unknown Facility

Houston, Texas, 77074, United States

Location

Unknown Facility

Houston, Texas, 77088, United States

Location

Unknown Facility

Irving, Texas, 75061, United States

Location

Unknown Facility

Mesquite, Texas, 75150, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

Unknown Facility

Sugar Land, Texas, 77479, United States

Location

Unknown Facility

Bountiful, Utah, 84010, United States

Location

Unknown Facility

West Jordan, Utah, 84088, United States

Location

Unknown Facility

Arlington, Virginia, 22205, United States

Location

Unknown Facility

Richmond, Virginia, 23294, United States

Location

Unknown Facility

Port Orchard, Washington, 98366, United States

Location

Unknown Facility

Seattle, Washington, 98122, United States

Location

Unknown Facility

Spokane, Washington, 99208, United States

Location

Unknown Facility

Tacoma, Washington, 98405, United States

Location

Unknown Facility

Morgantown, West Virginia, 26505, United States

Location

Unknown Facility

Camperdown, New South Wales, 2050, Australia

Location

Unknown Facility

Wollongong, New South Wales, 2522, Australia

Location

Unknown Facility

Birsbane, Queensland, 4152, Australia

Location

Unknown Facility

Daw Park, South Australia, 5041, Australia

Location

Unknown Facility

Woodville South, South Australia, 5011, Australia

Location

Unknown Facility

Hobart, Tasmania, 7000, Australia

Location

Unknown Facility

Clayton, Victoria, 3168, Australia

Location

Unknown Facility

Heidelberg, Victoria, 3081, Australia

Location

Unknown Facility

North Ballarat, Victoria, 3353, Australia

Location

Unknown Facility

Perth, Western Australia, 6000, Australia

Location

Unknown Facility

Malvern East, VIC3145, Australia

Location

Unknown Facility

Brussels, 1070, Belgium

Location

Unknown Facility

Gozée, 6534, Belgium

Location

Unknown Facility

Kortrijk, 8500, Belgium

Location

Unknown Facility

Mouscron, 7700, Belgium

Location

Unknown Facility

Yvoir, 5530, Belgium

Location

Unknown Facility

Coquitlam, British Columbia, V3K 3P4, Canada

Location

Unknown Facility

Kelowna, British Columbia, V1Y 3G8, Canada

Location

Unknown Facility

Penticton, British Columbia, V2A 5C8, Canada

Location

Unknown Facility

Ottawa, Ontario, K1S 1L2, Canada

Location

Unknown Facility

Thornhill, Ontario, L4J 1W3, Canada

Location

Unknown Facility

Toronto, Ontario, M9W 4L6, Canada

Location

Unknown Facility

Québec, Quebec, G1V 3M7, Canada

Location

Unknown Facility

Altenburg, 04600, Germany

Location

Unknown Facility

Dresden, 01307, Germany

Location

Unknown Facility

Eichstätt, 85072, Germany

Location

Unknown Facility

Christchurch, Canterbury, 8024, New Zealand

Location

Unknown Facility

Auckland, 1010, New Zealand

Location

Unknown Facility

Hamilton, 3240, New Zealand

Location

Unknown Facility

Papatoetoe, 2525, New Zealand

Location

Unknown Facility

Rotorua, 3010, New Zealand

Location

Unknown Facility

Tauranga, 3110, New Zealand

Location

Unknown Facility

Bloemfontein, 9301, South Africa

Location

Unknown Facility

Durban, 4037, South Africa

Location

Unknown Facility

Durban, 4067, South Africa

Location

Unknown Facility

Durban, 4092, South Africa

Location

Unknown Facility

East London, 5201, South Africa

Location

Unknown Facility

Johannesburg, 1724, South Africa

Location

Unknown Facility

Johannesburg, 2113, South Africa

Location

Unknown Facility

Paarl, 7646, South Africa

Location

Unknown Facility

Pretoria, 0084, South Africa

Location

Unknown Facility

Pretoria, 2000, South Africa

Location

Unknown Facility

Rondebosch, 7700, South Africa

Location

Unknown Facility

Stellenbosch, 7600, South Africa

Location

Unknown Facility

Thabazimbi, 0380, South Africa

Location

Unknown Facility

Worcester, 6850, South Africa

Location

Related Publications (2)

• 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.

  PMID: 35835008 DERIVED

• 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.

  PMID: 26190562 DERIVED

MeSH Terms

Conditions

Gout

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Vice President, Clinical Research and Development
• Organization: Ardea Biosciences, Inc.

sbaumgartner@ardeabio.com

858.652.6587

Study Officials

• S Baumgartner, MD

  Ardea Biosciences, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2011
• First Posted: July 12, 2011
• Study Start: July 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: March 1, 2013
• Last Updated: June 17, 2014
• Results First Posted: June 17, 2014

Record last verified: 2014-05

Locations

DE (3); US (127); CA (7); AU (11); BE (5); ZA (14); NZ (6)