The primary purpose of this study was to evaluate the effect of meloxicam tablets (7.5, 15 mg and 30 mg) with meloxicam placebo. Extended-release indomethacin capsules (75 mg) was an active control to assess trial sensitivity on bleeding time in healthy subjects. The secondary aim of this study was to assess effects of treatment on other platelet function and coagulation parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
82
Change from baseline in bleeding time
Time frame: up to 6 hours post-dose at day 8
Change from baseline in platelet aggregation
Time frame: up to 6 hours post-dose at day 8
Change from baseline in Platelet thromboxane B2 synthesis (TXB2 synthesis)
Time frame: up to 6 hours post-dose at day 8
Change in Thromboplastin Time (PT)
Time frame: up to 6 hours post-dose at day 8
Change in Activated Partial Thromboplastin Time (APTT)
Time frame: up to 6 hours post-dose at day 8
Change in Platelet Count
Time frame: up to 6 hours post-dose at day 8
Change in Leucocyte Activation
Time frame: Day 1 and 6 hours post-dose at day 8
Plasma levels of meloxicam
Time frame: pre-dose, 3 and 6 hours post-dose at day 8
Plasma levels of indomethacin
Time frame: pre-dose, 3 and 6 hours post-dose at day 8
Number of patients with adverse events
Time frame: up to 8 days
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