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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT No. 2009-009036-77 |
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| Name | Class |
|---|---|
| University of Oslo | OTHER |
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The purpose of this study is to determine whether paracetamol, ibuprofen or their combination can modify generation of radical oxygen species (ROS) from stimulated neutrophils.
Non-steroidal anti-inflammatory drugs (NSAID) are used to alleviate clinical inflammatory symptoms (e.g. pain, swelling and reduced function). Leukocytes, upon activation during inflammatory states, generate radical oxygen species (ROS) which primarily are intended for host defence against invading pathogens. Certain NSAID can modify the generation of ROS from stimulated neutrophils ranging form increased production to reduced production. Preliminary experiments in our laboratory have shown that different NSAIDs have opposing effects on the ability of leukocytes (granulocytes and monocytes) to produce ROS upon a standardized stimulus, i.e. phorbol myristate acetate (PMA). Paracetamol has a marked inhibitory effect and ibuprofen has a facilitating effect on ROS production. An inhibitory effect of paracetamol was also seen when examining platelet activation markers, whereas acetylsalicylic acid showed a clear enhancing effect in this respect. We want to examine if intake of paracetamol or ibuprofen in vivo have similar effects on leukocyte ROS production and platelet activation, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen 400 mg | Active Comparator | Ibuprofen oral single dose |
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| Ibuprofen 1200 mg | Active Comparator | Ibuprofen oral single dose |
|
| Paracetamol (acetaminophen) 1000 mg | Active Comparator | Paracetamol (acetaminophen) oral single dose |
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| Ibuprofen 400 mg + paracetamol 1000 mg | Active Comparator | Paracetamol (acetaminophen) + ibuprofen oral single dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug | Tablet ibuprofen 400 mg oral single dose (1 tablet) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Leukocyte radical oxygen species (ROS) production | 24 hours for each crossover event |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet activation status | 24 hours for each crossover event |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Torstein Lyberg, DDS, MD | Ullevaal University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ullevaal University Hospital | Oslo | NO-0407 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16891997 | Background | Stritesky Larssen K, Lyberg T. Oxidative status--age- and circadian variations?--a study in leukocytes/plasma. Neuro Endocrinol Lett. 2006 Aug;27(4):445-52. | |
| 16101529 | Background | Nagata M. Inflammatory cells and oxygen radicals. Curr Drug Targets Inflamm Allergy. 2005 Aug;4(4):503-4. doi: 10.2174/1568010054526322. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Ibuprofen | Drug | Tablets (2 x 600 mg) oral single dose (2 tablets) |
|
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| Paracetamol (acetaminophen) 1000 mg | Drug | Tablets (2 x 500 mg) oral single dose (2 tablets) |
|
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| Paracetamol + ibuprofen | Drug | Tablets (ibuprofen 400 mg + paracetamol (acetaminophen) 2 x 500 mg) single oral dose (3 tablets) |
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| 3032852 | Background | Nielsen VG, Webster RO. Inhibition of human polymorphonuclear leukocyte functions by ibuprofen. Immunopharmacology. 1987 Feb;13(1):61-71. doi: 10.1016/0162-3109(87)90027-0. |
| D000083 |
| Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |