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The objective of this study was to investigate the influence of meloxicam on low dose aspirin induced inhibition of platelet aggregation and thromboxane B2, when meloxicam is given before aspirin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meloxicam/Aspirin | Experimental | Meloxicam days 1-10 / Aspirin days 5-10 |
|
| Aspirin | Active Comparator | Aspirin 2 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meloxicam | Drug |
| ||
| Aspirin |
| Measure | Description | Time Frame |
|---|---|---|
| Arachidonic acid induced platelet aggregation | up to day 11 (treatment 1), up to day 3 (treatment 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Collagen-induced Platelet Aggregation | up to day 11 (treatment 1), up to day 3 (treatment 2) | |
| Adenosine diphosphate (ADP) Induced Platelet Aggregation | up to day 11 (treatment 1), up to day 3 (treatment 2) |
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Inclusion Criteria:
Exclusion Criteria:
For female subjects:
Ovarian hormone substitution and oral contraception have to be continued during the study
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| ID | Term |
|---|---|
| D000077239 | Meloxicam |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D013844 | Thiazoles |
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|
| Serum Thromboxane B2 production | up to day 11 (treatment 1), up to day 3 (treatment 2) |
| Number of patients with adverse events | up to 6 weeks |
| Number of patients with abnormal changes in laboratory parameters | up to day 11 (treatment 1), up to day 3 (treatment 2) |
| Number of patients with abnormal changes in 12-lead electrocardiogram (ECG) | Screening, 24 hours after the last Aspirin intake |
| Number of patients with clinically significant changes in vital signs | Screening, 24 hours after the last Aspirin intake |
| Assessment of tolerability on a 4-point scale | 24 hours after the last Aspirin intake |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |