Trial Review

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 registered on ANZCTR


Registration number
ACTRN12605000371695
Ethics application status
Approved
Date submitted
5/09/2005
Date registered
13/09/2005
Date last updated
29/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nonsteroidal drugs and the antiplatelet effects of aspirin
Scientific title
A randomised controlled double blinded study examining the interaction between NSAIDs and aspirin on platelet function in normal subjects.
Universal Trial Number (UTN)
Trial acronym
NADIA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Normal subjects 466 0
Condition category
Condition code
Other 543 543 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The drugs used in the study were naproxen 550mg (Synflex, Roche), ibuprofen 400mg (Brufen, Knoll) celecoxib 200mg (Celebrix, Pharmacia), indomethacin 25mg (Rheumacin 25, Pacific), tiaprofenic acid 300mg (Surgam SA, Aventis), sulindac 200mg (Daclin, Pacific), aspirin 300mg (Solprin, Reckitt Benckiser). Each drug was given two hours before a 300mg of aspirin.
Intervention code [1] 346 0
None
Comparator / control treatment
Placebo (Pacific Pharmaceuticals BN:C07331).
Control group
Placebo

Outcomes
Primary outcome [1] 634 0
Platelet function PFA-100
Timepoint [1] 634 0
12 hours after an NSAID dose and 24 hours after an NSAID followed by aspirin
Primary outcome [2] 635 0
Urine thromboxane B2
Timepoint [2] 635 0
12 hours after an NSAID dose and 24 hours after an NSAID followed by aspirin
Primary outcome [3] 636 0
Urine prostacyclin
Timepoint [3] 636 0
12 hours after an NSAID dose and 24 hours after an NSAID followed by aspirin
Secondary outcome [1] 1308 0
Adverse drug reactions
Timepoint [1] 1308 0
Within 48 hours from taking the NSAID.

Eligibility
Key inclusion criteria
Twelve healthy subjects were recruited from a large teaching hospital; all gave written informed consent.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of platelet dysfunction or a bleeding disorder, history of peptic or duodenal ulceration or gastritits, sensitivity or allergy to aspirin or NSAID, renal impairment with serum creatinine >0.12 mmol/L, haemoglobin < 120g/l, history of coronary artery disease, peripheral vascular or cerebrovascular disease, or congestive heart failure.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed numbered envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated; no blocking or stratification.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Two groups in parallel each receiving 3 NSAIDs and placebo in crossover fasion with 12 day washout
Phase
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 161 0
New Zealand
State/province [1] 161 0

Funding & Sponsors
Funding source category [1] 601 0
Government body
Name [1] 601 0
Greenlane Clinical Research Board
Country [1] 601 0
New Zealand
Primary sponsor type
Name
None
Address
Country
Secondary sponsor category [1] 490 0
None
Name [1] 490 0
None
Address [1] 490 0
Country [1] 490 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1697 0
Auckland Regional Ethics committee
Ethics committee address [1] 1697 0
Ethics committee country [1] 1697 0
New Zealand
Date submitted for ethics approval [1] 1697 0
Approval date [1] 1697 0
Ethics approval number [1] 1697 0

Summary
Brief summary
What does the study involve?

We plan to test 6 different non-steroidal anti-inflammatory drugs (NSAIDs) that are in common usage, in a sequential testing programme. We wish to analyse the effects each drug has on platelet function (the bloodâ¿¿s ability to clot) and to test whether there is an interaction with aspirin. There will be 2 groups of participants; participants in each group will take 3 NSAIDs.

If you agree to participate in this study you will have a blood and urine test and then take a dose of a NSAID. The dose will be the usual dose given to people with an inflammatory condition, such as arthritis. You will take a second dose of the drug twelve hours after the first dose. The next morning we will ask you to collect a sample of the first urine you pass that day and then re-attend our clinic for a further blood test. Following this you will receive a third and final dose of the specific NSAID. Two hours after this you will receive a dose of aspirin 300mg. The following morning on the third day we ask again that you collect a sample of your urine, as before, and also have a further blood test. 8-12 days then pass during which time you take no study drugs. On the active study days we ask that you abstain from taking any non-steroidal drugs or aspirin or other drugs/herbal medication that affect clotting.

The study then continues with another NSAID and goes through the same process as before with urine and blood tests. The cycle is repeated until you have worked through three of six non-steroidal drugs and a placebo (see diagram on next page). Another group of participants will take the other 3 drugs.

The study will take in entirety 8-10 weeks to complete. It is carried out with a number of visits to our outpatient area in ward 38, level 3, at Auckland City Hospital. There will be twelve visits in total. At each visit you will be supplied with a pack containing information, medication and specimen pots for collecting urine. You will be supplied with a diary.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35318 0
Address 35318 0
Country 35318 0
Phone 35318 0
Fax 35318 0
Email 35318 0
Contact person for public queries
Name 9535 0
Helen Farrell
Address 9535 0
Auckland City Hospital
Park Rd
Grafton Auckland 1007
Country 9535 0
New Zealand
Phone 9535 0
+64 9 3797440
Fax 9535 0
Email 9535 0
[email protected]
Contact person for scientific queries
Name 463 0
Dr. Patrick Gladding
Address 463 0
Auckland City Hospital
Park Rd
Grafton Auckland 1007
Country 463 0
New Zealand
Phone 463 0
+64 9 6369740
Fax 463 0
Email 463 0
[email protected]

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
No additional documents have been identified.