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

July 3, 2011 updated by: Ullevaal University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

7

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, NO-0407
        • Ullevaal University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ibuprofen 400 mg
Ibuprofen oral single dose
Drug: Ibuprofen
Tablet ibuprofen 400 mg oral single dose (1 tablet)
Other Names:
  • Ibumetin
  • ATC code: M01A E01
Drug: Ibuprofen
Tablets (2 x 600 mg) oral single dose (2 tablets)
Other Names:
  • Ibumetin
  • ATC code: M01A E01
Active Comparator: Ibuprofen 1200 mg
Ibuprofen oral single dose
Drug: Ibuprofen
Tablet ibuprofen 400 mg oral single dose (1 tablet)
Other Names:
  • Ibumetin
  • ATC code: M01A E01
Drug: Ibuprofen
Tablets (2 x 600 mg) oral single dose (2 tablets)
Other Names:
  • Ibumetin
  • 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:
  • Paracetamol
  • Acetaminophen
  • Ibumetin
  • ATC code: M01A E01
  • ATC code: N02B E01
  • Ibuprofen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Leukocyte radical oxygen species (ROS) production
Time Frame: 24 hours for each crossover event
24 hours for each crossover event

Secondary Outcome Measures

Outcome Measure
Time Frame
Platelet activation status
Time Frame: 24 hours for each crossover event
24 hours for each crossover event

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ullevaal University Hospital

Collaborators

University of Oslo

Investigators

  • Study Director: Torstein Lyberg, DDS, MD, Ullevaal University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

June 15, 2009

First Submitted That Met QC Criteria

June 15, 2009

First Posted (Estimate)

June 16, 2009

Study Record Updates

Last Update Posted (Estimate)

July 6, 2011

Last Update Submitted That Met QC Criteria

July 3, 2011

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PARIBU-024
  • EudraCT No. 2009-009036-77

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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