The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01391325




Registration number
NCT01391325
Ethics application status
Date submitted
7/07/2011
Date registered
12/07/2011
Date last updated
17/06/2014

Titles & IDs
Public title
Allopurinol Outcome Study
Scientific title
Long-term Allopurinol Safety Study Evaluating Outcomes in Gout Patients (LASSO)
Secondary ID [1] 0 0
ALLO-401
Universal Trial Number (UTN)
Trial acronym
LASSO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Allopurinol

Other: Allopurinol - Treatment.


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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety of Allopurinol - Proportion of subjects who experienced at least one Treatment Emergent Adverse Event (TEAE) during the study.
Timepoint [1] 0 0
Every month for 6 months.
Secondary outcome [1] 0 0
Proportion of Subjects With Serum Urate (sUA) Less Than 6.0 mg/dL - Proportion of subjects with serum urate (sUA) less than 6.0 mg/dL at Month 6 using Last Observation Carried Forward (LOCF) for subjects with missing values at Month 6.
Timepoint [1] 0 0
Month 6
Secondary outcome [2] 0 0
Incidence of Gout Flares - Proportion of subjects who experienced at least one gout flare requiring treatment during the study.
Timepoint [2] 0 0
Every month for 6 months.
Secondary outcome [3] 0 0
Mean Change From Baseline to Month 6 in SF-36 PCS+MCS - The SF-36 is a short-form health survey with 36 questions that yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical (PCS) and mental health (MCS) summary. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability. The higher the score the less disability. The component scores (PCS and MCS) are norm-based to a standard population with a mean of 50 and a standard deviation of 10.
Timepoint [3] 0 0
Month 6

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Wollongong
Recruitment hospital [3] 0 0
- Birsbane
Recruitment hospital [4] 0 0
- Daw Park
Recruitment hospital [5] 0 0
- Woodville South
Recruitment hospital [6] 0 0
- Hobart
Recruitment hospital [7] 0 0
- Clayton
Recruitment hospital [8] 0 0
- Heidelberg
Recruitment hospital [9] 0 0
- North Ballarat
Recruitment hospital [10] 0 0
- Perth
Recruitment hospital [11] 0 0
- Malvern East
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2522 - Wollongong
Recruitment postcode(s) [3] 0 0
4152 - Birsbane
Recruitment postcode(s) [4] 0 0
5041 - Daw Park
Recruitment postcode(s) [5] 0 0
5011 - Woodville South
Recruitment postcode(s) [6] 0 0
7000 - Hobart
Recruitment postcode(s) [7] 0 0
3168 - Clayton
Recruitment postcode(s) [8] 0 0
3081 - Heidelberg
Recruitment postcode(s) [9] 0 0
3353 - North Ballarat
Recruitment postcode(s) [10] 0 0
6000 - Perth
Recruitment postcode(s) [11] 0 0
VIC3145 - Malvern East
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Hawaii
Country [10] 0 0
United States of America
State/province [10] 0 0
Idaho
Country [11] 0 0
United States of America
State/province [11] 0 0
Illinois
Country [12] 0 0
United States of America
State/province [12] 0 0
Indiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Louisiana
Country [15] 0 0
United States of America
State/province [15] 0 0
Maryland
Country [16] 0 0
United States of America
State/province [16] 0 0
Massachusetts
Country [17] 0 0
United States of America
State/province [17] 0 0
Michigan
Country [18] 0 0
United States of America
State/province [18] 0 0
Minnesota
Country [19] 0 0
United States of America
State/province [19] 0 0
Mississippi
Country [20] 0 0
United States of America
State/province [20] 0 0
Missouri
Country [21] 0 0
United States of America
State/province [21] 0 0
Nebraska
Country [22] 0 0
United States of America
State/province [22] 0 0
Nevada
Country [23] 0 0
United States of America
State/province [23] 0 0
New Hampshire
Country [24] 0 0
United States of America
State/province [24] 0 0
New Mexico
Country [25] 0 0
United States of America
State/province [25] 0 0
New York
Country [26] 0 0
United States of America
State/province [26] 0 0
North Carolina
Country [27] 0 0
United States of America
State/province [27] 0 0
North Dakota
Country [28] 0 0
United States of America
State/province [28] 0 0
Ohio
Country [29] 0 0
United States of America
State/province [29] 0 0
Oklahoma
Country [30] 0 0
United States of America
State/province [30] 0 0
Oregon
Country [31] 0 0
United States of America
State/province [31] 0 0
Pennsylvania
Country [32] 0 0
United States of America
State/province [32] 0 0
South Carolina
Country [33] 0 0
United States of America
State/province [33] 0 0
Tennessee
Country [34] 0 0
United States of America
State/province [34] 0 0
Texas
Country [35] 0 0
United States of America
State/province [35] 0 0
Utah
Country [36] 0 0
United States of America
State/province [36] 0 0
Virginia
Country [37] 0 0
United States of America
State/province [37] 0 0
Washington
Country [38] 0 0
United States of America
State/province [38] 0 0
West Virginia
Country [39] 0 0
Belgium
State/province [39] 0 0
Bruxelles
Country [40] 0 0
Belgium
State/province [40] 0 0
Gozee
Country [41] 0 0
Belgium
State/province [41] 0 0
Kortrijk
Country [42] 0 0
Belgium
State/province [42] 0 0
Mouscron
Country [43] 0 0
Belgium
State/province [43] 0 0
Yvoir
Country [44] 0 0
Canada
State/province [44] 0 0
British Columbia
Country [45] 0 0
Canada
State/province [45] 0 0
Ontario
Country [46] 0 0
Canada
State/province [46] 0 0
Quebec
Country [47] 0 0
Germany
State/province [47] 0 0
Altenburg
Country [48] 0 0
Germany
State/province [48] 0 0
Dresden
Country [49] 0 0
Germany
State/province [49] 0 0
Eichstatt
Country [50] 0 0
New Zealand
State/province [50] 0 0
Canterbury
Country [51] 0 0
New Zealand
State/province [51] 0 0
Auckland
Country [52] 0 0
New Zealand
State/province [52] 0 0
Hamilton
Country [53] 0 0
New Zealand
State/province [53] 0 0
Papatoetoe
Country [54] 0 0
New Zealand
State/province [54] 0 0
Rotorua
Country [55] 0 0
New Zealand
State/province [55] 0 0
Tauranga
Country [56] 0 0
South Africa
State/province [56] 0 0
Bloemfontein
Country [57] 0 0
South Africa
State/province [57] 0 0
Durban
Country [58] 0 0
South Africa
State/province [58] 0 0
East London
Country [59] 0 0
South Africa
State/province [59] 0 0
Johannesburg
Country [60] 0 0
South Africa
State/province [60] 0 0
Paarl
Country [61] 0 0
South Africa
State/province [61] 0 0
Pretoria
Country [62] 0 0
South Africa
State/province [62] 0 0
Rondebosch
Country [63] 0 0
South Africa
State/province [63] 0 0
Stellenbosch
Country [64] 0 0
South Africa
State/province [64] 0 0
Thabazimbi
Country [65] 0 0
South Africa
State/province [65] 0 0
Worcester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ardea Biosciences, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01391325
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
S Baumgartner, MD
Address 0 0
Ardea Biosciences, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications