Effect of Ibuprofen, Paracetamol and Their Combination on Radical Oxygen Species (ROS) Production
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain |
Drug: Ibuprofen Drug: Paracetamol (acetaminophen) 1000 mg Drug: Paracetamol + ibuprofen |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | The Effect of Ibuprofen, Paracetamol and Their Combination on Reactive Oxygen Species (ROS)- Production in Leukocytes and Platelet Activation |
- Leukocyte radical oxygen species (ROS) production [ Time Frame: 24 hours for each crossover event ] [ Designated as safety issue: No ]
- Platelet activation status [ Time Frame: 24 hours for each crossover event ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 7 |
| Study Start Date: | May 2009 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Ibuprofen 400 mg
Ibuprofen oral single dose
|
Drug: Ibuprofen
Tablet ibuprofen 400 mg oral single dose (1 tablet)
Other Names:
|
|
Active Comparator: Ibuprofen 1200 mg
Ibuprofen oral single dose
|
Drug: Ibuprofen
Tablets (2 x 600 mg) oral single dose (2 tablets)
Other Names:
|
|
Active Comparator: Paracetamol (acetaminophen) 1000 mg
Paracetamol (acetaminophen) oral single dose
|
Drug: Paracetamol (acetaminophen) 1000 mg
Tablets (2 x 500 mg) oral single dose (2 tablets)
Other Names:
|
|
Active Comparator: Ibuprofen 400 mg + paracetamol 1000 mg
Paracetamol (acetaminophen) + ibuprofen oral single dose
|
Drug: Paracetamol + ibuprofen
Tablets (ibuprofen 400 mg + paracetamol (acetaminophen) 2 x 500 mg) single oral dose (3 tablets)
Other Names:
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Volunteers of both sexes (ASA type I).
- Females who are not pregnant or plan conception. (A pregnancy test will be conducted before each test day)
- Persons who have not used analgesics for 3 days prior to the blood sampling.
- Persons without known active peptic ulcer or gastrointestinal bleeding.
- Persons without any known hypersensitivity for NSAIDs.
- Persons under no other drug treatment than contraceptives.
- Age 18 to 35 years of Caucasian origin
Exclusion Criteria:
- Pregnancy during the test period.
- Development of active peptic ulcer during the test period.
- Change in medication status during the test period (after inclusion).
Contacts and Locations| Norway | |
| Ullevaal University Hospital | |
| Oslo, Norway, NO-0407 | |
| Study Director: | Torstein Lyberg, DDS, MD | Ullevaal University Hospital |
More Information
Publications:
| Responsible Party: | Professor Torstein Lyberg, Ullevaal University Hospital |
| ClinicalTrials.gov Identifier: | NCT00921505 History of Changes |
| Other Study ID Numbers: | PARIBU-024, EudraCT No. 2009-009036-77 |
| Study First Received: | June 15, 2009 |
| Last Updated: | July 3, 2011 |
| Health Authority: | Norway:National Committee for Medical and Health Research Ethics Norway: Norwegian Medicines Agency Norway: Norwegian Social Science Data Services |
Keywords provided by Oslo University Hospital:
|
Acetaminophen Ibuprofen Platelets Leukocytes Oxygen species |
Humans Blood Platelets Reactive Oxygen Species Platelet Activation |
Additional relevant MeSH terms:
|
Acetaminophen Ibuprofen Antipyretics Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Central Nervous System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013