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Effect of Ibuprofen, Paracetamol and Their Combination on Radical Oxygen Species (ROS) Production

This study has been completed.
Sponsor:
Collaborator:
University of Oslo
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00921505
First received: June 15, 2009
Last updated: July 3, 2011
Last verified: March 2009
  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

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Leukocyte radical oxygen species (ROS) production [ Time Frame: 24 hours for each crossover event ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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:
  • Ibumetin
  • ibuprofen
  • ATC code: M01A E01
Active Comparator: Ibuprofen 1200 mg
Ibuprofen oral single dose
Drug: Ibuprofen
Tablets (2 x 600 mg) oral single dose (2 tablets)
Other Names:
  • Ibumetin
  • Ibuprofen
  • ATC code: M01A E01
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:
  • Paracetamol
  • Acetaminophen
  • ATC code: N02B E01
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:
  • Ibumetin
  • Ibuprofen
  • ATC code: M01A E01
  • Paracetamol
  • Acetaminophen
  • ATC code: N02B E01

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
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00921505

Locations
Norway
Ullevaal University Hospital
Oslo, Norway, NO-0407
Sponsors and Collaborators
Ullevaal University Hospital
University of Oslo
Investigators
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
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014