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Allopurinol Outcome Study

Information source: Ardea Biosciences, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gout

Intervention: Allopurinol (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Ardea Biosciences, Inc.

Official(s) and/or principal investigator(s):
S Baumgartner, MD, Study Director, Affiliation: Ardea Biosciences, Inc.

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.

Clinical Details

Official title: Long-term Allopurinol Safety Study Evaluating Outcomes in Gout Patients (LASSO)

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Safety of Allopurinol

Secondary outcome:

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

Incidence of Gout Flares

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

Eligibility

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Locations and Contacts

Malvern East VIC3145, Australia

Bruxelles 1070, Belgium

Gozee 6534, Belgium

Kortrijk 8500, Belgium

Mouscron 7700, Belgium

Yvoir 5530, Belgium

Quebec G1V 3M7, Canada

Altenburg 04600, Germany

Dresden 01307, Germany

Eichstatt 85072, Germany

Auckland 1010, New Zealand

Hamilton 3240, New Zealand

Papatoetoe 2525, New Zealand

Rotorua 3010, New Zealand

Tauranga 3110, New Zealand

Bloemfontein 9301, South Africa

Durban 4037, South Africa

Durban 4067, South Africa

Durban 4092, South Africa

East London 5201, South Africa

Johannesburg 2113, South Africa

Johannesburg 1724, South Africa

Paarl 7646, South Africa

Pretoria 0084, South Africa

Pretoria 2000, South Africa

Rondebosch 7700, South Africa

Stellenbosch 7600, South Africa

Thabazimbi 0380, South Africa

Worcester 6850, South Africa

Birmingham, Alabama 35242, United States

Birmingham, Alabama 35294, United States

Bringham, Alabama 35216, United States

Calera, Alabama 35040, United States

Huntsville, Alabama 35801, United States

Mobile, Alabama 36608, United States

Chandlers, Arizona 85224, United States

Green Valley, Arizona 85614, United States

Jonesboro, Arizona 72401, United States

Phoenix, Arizona 85028, United States

Phoenix, Arizona 85050, United States

Tucson, Arizona 85704, United States

Little Rock, Arkansas 72204, United States

Little Rock, Arkansas 72205, United States

Coquitlam, British Columbia V3K 3P4, Canada

Kelowna, British Columbia V1Y 3G8, Canada

Penticton, British Columbia V2A 5C8, Canada

Anaheim, California 92805, United States

Carmichael, California 95608, United States

Covina, California 91723, United States

Hemet, California 92543, United States

Irvine, California 92618, United States

Los Angeles, California 90048, United States

Mission Viejo, California 92691, United States

Pasadena, California 91107, United States

Sacramento, California 95816, United States

San Diego, California 92108, United States

San Ramon, California 94583, United States

Santa Maria, California 93454, United States

Weslake Village, California 91361, United States

Christchurch, Canterbury 8024, New Zealand

Denver, Colorado 80220, United States

Englewood, Colorado 80113, United States

Danbury, Connecticut 06810, United States

Trumbull, Connecticut 06611, United States

Brandenton, Florida 34208, United States

Brandon, Florida 33511, United States

Brooksville, Florida 34601, United States

East Brandenton, Florida 34208, United States

Fleming Island, Florida 32003, United States

Jacksonville, Florida 32205, United States

Jacksonville, Florida 32216, United States

Jupiter, Florida 33458, United States

Miami, Florida 33135, United States

Oldsmar, Florida 34677, United States

Orlando, Florida 32804, United States

Ormond Beach, Florida 32174, United States

Plant City, Florida 33563, United States

Port Orange, Florida 32127, United States

Sanford, Florida 32771, United States

St. Petersburg, Florida 33709, United States

Tampa, Florida 33606, United States

Vero Beach, Florida 32960, United States

Winter Haven, Florida 33880, United States

Zephyrhills, Florida 33542, United States

Atlanta, Georgia 30308, United States

Newnan, Georgia 30265, United States

Honolulu, Hawaii 96814, United States

Meridian, Idaho 83646, United States

Addison, Illinois 60101, United States

Chicago, Illinois 60612, United States

Chicago, Illinois 60637, United States

Gurnee, Illinois 60031, United States

Evansville, Indiana 47713, United States

Elizabethtown, Kentucky 42701, United States

Lexington, Kentucky 40504, United States

Louisville, Kentucky 40213, United States

Monroe, Louisiana 71203, United States

Cumberland, Maryland 21502, United States

Frederick, Maryland 21702, United States

Hagerstown, Maryland 21740, United States

Wheaton, Maryland 20902, United States

Hyannis, Massachusetts 02601, United States

Worcester, Massachusetts 01605, United States

South Traverse City, Michigan 49684, United States

Rochester, Minnesota 55905, United States

Olive Branch, Mississippi 38654, United States

Florissant, Missouri 63031, United States

Kansas City, Missouri 64114, United States

Saint Louis, Missouri 63117, United States

St. Louis, Missouri 63128, United States

Omaha, Nebraska 68114, United States

Las Vegas, Nevada 89119, United States

Reno, Nevada 89502, United States

Nashua, New Hampshire 03060, United States

Albuquerque, New Mexico 87102, United States

Albuquerque, New Mexico 87106, United States

Camperdown, New South Wales 2050, Australia

Wollongong, New South Wales 2522, Australia

Albany, New York 12206, United States

Endwell, New York 13760, United States

Hartsdale, New York 10530, United States

Charlotte, North Carolina 28210, United States

Harrisburg, North Carolina 28075, United States

Hickory, North Carolina 28602, United States

Raleigh, North Carolina 27609, United States

Raleigh, North Carolina 27612, United States

Wilmington, North Carolina 28401, United States

Fargo, North Dakota 58103, United States

Cincinnati, Ohio 45224, United States

Cincinnati, Ohio 45242, United States

Cleveland, Ohio 44122, United States

Columbus, Ohio 43203, United States

Dayton, Ohio 45417, United States

Middleburg Heights, Ohio 44130, United States

Oklahoma City, Oklahoma 73103, United States

Ottawa, Ontario K1S 1L2, Canada

Thornhill, Ontario L4J 1W3, Canada

Toronto, Ontario M9W 4L6, Canada

Eugene, Oregon 97402, United States

Portland, Oregon 97220, United States

Altoona, Pennsylvania 16602, United States

Duncansville, Pennsylvania 16635, United States

Lancaster, Pennsylvania 17601, United States

Birsbane, Queensland 4152, Australia

Daw Park, South Australia 5041, Australia

Woodville South, South Australia 5011, Australia

Charleston, South Carolina 29407, United States

Mount Pleasant, South Carolina 29464, United States

Spartanburg, South Carolina 29303, United States

Hobart, Tasmania 7000, Australia

Jackson, Tennessee 38305, United States

Spring Hill, Tennessee 37174, United States

Dallas, Texas 75216, United States

Dallas, Texas 75235, United States

Houston, Texas 77088, United States

Houston, Texas 77074, United States

Irving, Texas 75061, United States

Mesquite, Texas 75150, United States

San Antonio, Texas 78229, United States

Sugar Land, Texas 77479, United States

Bountiful, Utah 84010, United States

West Jordan, Utah 84088, United States

Clayton, Victoria 3168, Australia

Heidelberg, Victoria 3081, Australia

North Ballarat, Victoria 3353, Australia

Arlington, Virginia 22205, United States

Richmond, Virginia 23294, United States

Port Orchard, Washington 98366, United States

Seattle, Washington 98122, United States

Spokane, Washington 99208, United States

Tacoma, Washington 98405, United States

Morgantown, West Virginia 26505, United States

Perth, Western Australia 6000, Australia

Additional Information

Starting date: July 2011
Last updated: May 16, 2014

Page last updated: August 23, 2015

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