Skip to main content
OpenTrials
Completed

NCT Number: NCT00921505

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ullevaal University Hospital

Oslo, NO-0407, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Ibuprofen

Drug

Tablet ibuprofen 400 mg oral single dose (1 tablet)

Other names: Ibumetin, ATC code: M01A E01

Paracetamol (acetaminophen) 1000 mg

Drug

Tablets (2 x 500 mg) oral single dose (2 tablets)

Other names: Paracetamol, Acetaminophen, ATC code: N02B E01

Paracetamol + ibuprofen

Drug

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

Primary outcomes

  1. Leukocyte radical oxygen species (ROS) production

    Time frame: 24 hours for each crossover event

Secondary outcomes

  1. Platelet activation status

    Time frame: 24 hours for each crossover event

Sponsors and collaborators

Lead sponsor

Ullevaal University Hospital

Other

Collaborators

  • University of Oslo

Registry information

Official study title

The Effect of Ibuprofen, Paracetamol and Their Combination on Reactive Oxygen Species (ROS)- Production in Leukocytes and Platelet Activation

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 16, 2009
Registry last updated
Jul 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.