Effect of Ibuprofen, Paracetamol and Their Combination on Radical Oxygen Species (ROS) Production
Information source: Ullevaal University Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Ibuprofen (Drug); Ibuprofen (Drug); Paracetamol (acetaminophen) 1000 mg (Drug); Paracetamol + ibuprofen (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Ullevaal University Hospital Official(s) and/or principal investigator(s):
Torstein Lyberg, DDS, MD, Study Director, Affiliation: Ullevaal University Hospital
Overall contact:
Gaute Lyngstad, DDS, Phone: 004722844673, Email: gautelyn@odont.uio.no
Summary
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.
Clinical Details
Official title: The Effect of Ibuprofen, Paracetamol and Their Combination on Reactive Oxygen Species (ROS)- Production in Leukocytes and Platelet Activation
Study design: Basic Science, Non-Randomized, Open Label, Historical Control, Crossover Assignment, Pharmacodynamics Study
Primary outcome: Leukocyte radical oxygen species (ROS) production
Secondary outcome: Platelet activation status
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
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Both.
Criteria:
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).
Locations and Contacts
Gaute Lyngstad, DDS, Phone: 004722844673, Email: gautelyn@odont.uio.no
Ullevaal University Hospital, Oslo NO-0407, Norway; Recruiting
Gaute Lyngstad, DDS, Phone: 004722844673, Email: gautelyn@odont.uio.no
Lasse A Skoglund, DDS, DSci, Phone: 004722844672, Email: lasses@odont.uio.no
Gaute Lyngstad, DDS, Principal Investigator
Additional Information
Related publications: 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. Nagata M. Inflammatory cells and oxygen radicals. Curr Drug Targets Inflamm Allergy. 2005 Aug;4(4):503-4. Review. Nielsen VG, Webster RO. Inhibition of human polymorphonuclear leukocyte functions by ibuprofen. Immunopharmacology. 1987 Feb;13(1):61-71.
Starting date: May 2009
Ending date: December 2009
Last updated: June 15, 2009
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