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Trial details imported from ClinicalTrials.gov

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

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01391325