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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Ibuprofen 400 mg

Ibuprofen oral single dose

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

Tablet ibuprofen 400 mg oral single dose (1 tablet)

Ibuprofen 1200 mg

Ibuprofen oral single dose

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

Tablets (2 x 600 mg) oral single dose (2 tablets)

Paracetamol (acetaminophen) 1000 mg

Paracetamol (acetaminophen) oral single dose

Group Type ACTIVE_COMPARATOR

Paracetamol (acetaminophen) 1000 mg

Intervention Type DRUG

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

Ibuprofen 400 mg + paracetamol 1000 mg

Paracetamol (acetaminophen) + ibuprofen oral single dose

Group Type ACTIVE_COMPARATOR

Paracetamol + ibuprofen

Intervention Type DRUG

Tablets (ibuprofen 400 mg + paracetamol (acetaminophen) 2 x 500 mg) single oral dose (3 tablets)

Interventions

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Ibuprofen

Tablet ibuprofen 400 mg oral single dose (1 tablet)

Intervention Type DRUG

Ibuprofen

Tablets (2 x 600 mg) oral single dose (2 tablets)

Intervention Type DRUG

Paracetamol (acetaminophen) 1000 mg

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

Intervention Type DRUG

Paracetamol + ibuprofen

Tablets (ibuprofen 400 mg + paracetamol (acetaminophen) 2 x 500 mg) single oral dose (3 tablets)

Intervention Type DRUG

Other Intervention Names

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Ibumetin ATC code: M01A E01 Ibumetin ATC code: M01A E01 Paracetamol Acetaminophen ATC code: N02B E01 Ibumetin Ibuprofen ATC code: M01A E01 Paracetamol Acetaminophen ATC code: N02B E01

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No