None listed
Conditions
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.
Interventions
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.
Sponsors
None
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
Twelve healthy subjects were recruited from a large teaching hospital; all gave written informed consent.
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.
Outcome results
None listed