Clinical trial NCT01391325: Allopurinol Outcome Study
Official title: Long-term Allopurinol Safety Study Evaluating Outcomes in Gout Patients (LASSO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gout
Lead sponsor: Ardea Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2011-07-12
Enrollment: 1735
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Safety of Allopurinol
timeFrame: Every month for 6 months.
Secondary outcomes:
measure: Proportion of Subjects With Serum Urate (sUA) Less Than 6.0 mg/dL
timeFrame: Month 6
measure: Incidence of Gout Flares
timeFrame: Every month for 6 months.
measure: Mean Change From Baseline to Month 6 in SF-36 PCS+MCS
timeFrame: Month 6
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Bringham
country: United States
state: Alabama
city: Calera
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Chandlers
country: United States
state: Arizona
city: Green Valley
country: United States
state: Arizona
city: Jonesboro
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: Carmichael
country: United States
state: California
city: Covina
country: United States
state: California
city: Hemet
country: United States
state: California
city: Irvine
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Mission Viejo
country: United States
state: California
city: Pasadena
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Ramon
country: United States
state: California
city: Santa Maria
country: United States
state: California
city: Weslake Village
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Englewood
country: United States
state: Colorado
city: Danbury
country: United States
state: Connecticut
city: Trumbull
country: United States
state: Connecticut
city: Brandenton
country: United States
state: Florida
city: Brandon
country: United States
state: Florida
city: Brooksville
country: United States
state: Florida
city: East Brandenton
country: United States
state: Florida
city: Fleming Island
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Jupiter
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Oldsmar
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Ormond Beach
country: United States
state: Florida
city: Plant City
country: United States
state: Florida
city: Port Orange
country: United States
state: Florida
city: Sanford
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Vero Beach
country: United States
state: Florida
city: Winter Haven
country: United States
state: Florida
city: Zephyrhills
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Newnan
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Meridian
country: United States
state: Idaho
city: Addison
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Gurnee
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Elizabethtown
country: United States
state: Kentucky
city: Lexington
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Monroe
country: United States
state: Louisiana
city: Cumberland
country: United States
state: Maryland
city: Frederick
country: United States
state: Maryland
city: Hagerstown
country: United States
state: Maryland
city: Wheaton
country: United States
state: Maryland
city: Hyannis
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: South Traverse City
country: United States
state: Michigan
city: Rochester
country: United States
state: Minnesota
city: Olive Branch
country: United States
state: Mississippi
city: Florissant
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Reno
country: United States
state: Nevada
city: Nashua
country: United States
state: New Hampshire
city: Albuquerque
country: United States
state: New Mexico
city: Albuquerque
country: United States
state: New Mexico
city: Albany
country: United States
state: New York
city: Endwell
country: United States
state: New York
city: Hartsdale
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Harrisburg
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Middleburg Heights
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Eugene
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Altoona
country: United States
state: Pennsylvania
city: Duncansville
country: United States
state: Pennsylvania
city: Lancaster
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Mount Pleasant
country: United States
state: South Carolina
city: Spartanburg
country: United States
state: South Carolina
city: Jackson
country: United States
state: Tennessee
city: Spring Hill
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Irving
country: United States
state: Texas
city: Mesquite
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Sugar Land
country: United States
state: Texas
city: Bountiful
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: Arlington
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Port Orchard
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Morgantown
country: United States
state: West Virginia
city: Camperdown
country: Australia
state: New South Wales
city: Wollongong
country: Australia
state: New South Wales
city: Birsbane
country: Australia
state: Queensland
city: Daw Park
country: Australia
state: South Australia
city: Woodville South
country: Australia
state: South Australia
city: Hobart
country: Australia
state: Tasmania
city: Clayton
country: Australia
state: Victoria
city: Heidelberg
country: Australia
state: Victoria
city: North Ballarat
country: Australia
state: Victoria
city: Perth
country: Australia
state: Western Australia
city: Malvern East
country: Australia
city: Bruxelles
country: Belgium
city: Gozee
country: Belgium
city: Kortrijk
country: Belgium
city: Mouscron
country: Belgium
city: Yvoir
country: Belgium
city: Coquitlam
country: Canada
state: British Columbia
city: Kelowna
country: Canada
state: British Columbia
city: Penticton
country: Canada
state: British Columbia
city: Ottawa
country: Canada
state: Ontario
city: Thornhill
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Quebec
country: Canada
city: Altenburg
country: Germany
city: Dresden
country: Germany
city: Eichstatt
country: Germany
city: Christchurch
country: New Zealand
state: Canterbury
city: Auckland
country: New Zealand
city: Hamilton
country: New Zealand
city: Papatoetoe
country: New Zealand
city: Rotorua
country: New Zealand
city: Tauranga
country: New Zealand
city: Bloemfontein
country: South Africa
city: Durban
country: South Africa
city: Durban
country: South Africa
city: Durban
country: South Africa
city: East London
country: South Africa
city: Johannesburg
country: South Africa
city: Johannesburg
country: South Africa
city: Paarl
country: South Africa
city: Pretoria
country: South Africa
city: Pretoria
country: South Africa
city: Rondebosch
country: South Africa
city: Stellenbosch
country: South Africa
city: Thabazimbi
country: South Africa
city: Worcester
country: South Africa
Study officials:
affiliation: Ardea Biosciences, Inc.
name: S Baumgartner, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.