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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
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
Timepoint [1] 0 0
Month 6
Secondary outcome [2] 0 0
Incidence of Gout Flares
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
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
Sex
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
1/07/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2013
Sample size
Target
Accrual to date
Final
1735
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
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3168 - Clayton
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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
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Alabama
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Louisiana
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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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01391325