Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000477426
Ethics application status
Approved
Date submitted
5/09/2007
Date registered
21/09/2007
Date last updated
21/09/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of aspirin and a blood pressure medicine on the blood concentrations of allopurinol, a common treatment for gout
Scientific title
The effect of low-dose aspirin and/ or hydrochlorothiazide (HCT) on the pharmacokinetics and pharmacodynamics of allopurinol in healthy volunteers
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Potential drug interaction(s) between low-dose aspirin, hydrochlorothiazide (HCT) and allopurinol 2241 0
Condition category
Condition code
Musculoskeletal 2334 2334 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Healthy volunteers not taking any regular medication, including herbal medicines, will be will be treated in a randomised order with a single dose of allopurinol (control; 600 mg), and with allopurinol combined with a single dose of aspirin (100 mg), with a single dose of HCT (25 mg) and with the combination, aspirin and HCT.
All drugs will be administered orally.
Urine (3 x 2 h sequential collections) and blood samples (3 mid-point blood samples) will be collected over 6 h. Blood and urine will be analysed for uric acid and plasma and urinary oxypurinol concentrations.
There will be a washout period of 1 week between each treatment.
Intervention code [1] 1955 0
Treatment: Drugs
Comparator / control treatment
Allopurinol alone (600 mg (control)), administered orally.
Control group
Active

Outcomes
Primary outcome [1] 3229 0
To determine whether taking aspirin and HCT concomitantly with allopurinol will affect the pharmacokinetics of allopurinol as determined by oxypurinol clearance and/or the pharmacodynamic endpoint, the plasma and urinary concentrations of urate.
Timepoint [1] 3229 0
4 study days, each with 3 timepoints for the collection of urine and blood for analysis. i.e. 12 blood and urines will be collected per subject over the entire trial.
Secondary outcome [1] 5388 0
n/a
Timepoint [1] 5388 0
n/a

Eligibility
Key inclusion criteria
Inclusion Criteria:
1) Male or female with Body Mass Index (BMI) between 20 and 30 kg/ m 2) Healthy, as determined by a medical examination, medical history and normal biochemical and haematological values.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Medical condition or abnormality that, in the opinion of the investigators would preclude him or her from participation, 2) History of cardiovascular disease, diabetes or renal disease, 3) On medications likely to affect urate clearance, including Non Steriodal Anti Inflammatory Drugs (NSAIDs), Angiotensin Converting Enzyme (ACE) inhibitors and lipid lowering drugs, 4) A diet which has the potential to interfere with the study outcomes, e.g. raise uric acid concentrations, and is unwilling to discontinue consuming such food/ drink for the duration of the study, 5) History of substance abuse or drug addiction or consumes more than 21 standard drinks per week, 6) Abnormal laboratory test results (outside 2 standard deviations from the mean)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects undergo a phone screen and if elegible, they attend a screening visit where a physical examination is conducted. Blood and urine samples are collected and if all results are normal, the subject is enrolled into the study.
No explicit attempt was made to conceal allocation of subjects to a particular sequence for the treatments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A series of possible sequences was placed in a bag and then matched for each subject.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
18/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2495 0
Hospital
Name [1] 2495 0
St Vincent?s Clinical Trials Account and Professor Richard Day General Purpose Fund
Country [1] 2495 0
Australia
Funding source category [2] 2596 0
Hospital
Name [2] 2596 0
St Vincent's Hospital Sydney Ltd
Country [2] 2596 0
Australia
Primary sponsor type
Individual
Name
Professor Richard Day
Address
Clinical Pharmacology and Toxicology
Xavier Level 2, St Vincent’s Hospital
Victoria Street, Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 2263 0
None
Name [1] 2263 0
Address [1] 2263 0
Country [1] 2263 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4404 0
St Vincent's Hospital Research Ethics Committee, Sydney
Ethics committee address [1] 4404 0
St Vincent's Hospital
Victoria Street, Darlinghurst NSW 2010
Ethics committee country [1] 4404 0
Australia
Date submitted for ethics approval [1] 4404 0
18/06/2007
Approval date [1] 4404 0
25/06/2007
Ethics approval number [1] 4404 0
H 07/037

Summary
Brief summary
Gout is an inflammatory condition caused by the deposition of urate crystals in tissues/joints. Allopurinol is a common and effective treatment to prevent gout. Gout predominantly affects the older population who are at risk for cardiovascular disease such as hypertension and heart attack. Low-dose aspirin and hydrochlorothiazide are used for the prevention of such cardiovascular events. Therefore, co-administration of allopurinol and aspirin and/or hydrochlorothiazide is common in older individuals. However, there has been no investigation of this combination of drugs with respect to control of urate concentrations in the body. This study will examine the interaction between allopurinol and aspirin and hydrochlorothiazide.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27976 0
Address 27976 0
Country 27976 0
Phone 27976 0
Fax 27976 0
Email 27976 0
Contact person for public queries
Name 11133 0
Professor Richard Day
Address 11133 0
Clinical Pharmacology and Toxicology
Xavier Level 2, St Vincent’s Hospital
Victoria Street, Darlinghurst NSW 2010
Country 11133 0
Australia
Phone 11133 0
83822304
Fax 11133 0
Email 11133 0
cpt@unsw.edu.au
Contact person for scientific queries
Name 2061 0
Professor Richard Day
Address 2061 0
Clinical Pharmacology and Toxicology
Xavier Level 2, St Vincent’s Hospital
Victoria Street, Darlinghurst NSW 2010
Country 2061 0
Australia
Phone 2061 0
83822304
Fax 2061 0
Email 2061 0
cpt@unsw.edu.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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