NCT00921505

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_4 pain

Timeline
Completed

Started May 2009

Shorter than P25 for phase_4 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

July 6, 2011

Status Verified

March 1, 2009

Enrollment Period

8 months

First QC Date

June 15, 2009

Last Update Submit

July 3, 2011

Conditions

Pain

Keywords

AcetaminophenIbuprofenPlateletsLeukocytesOxygen speciesHumansBlood PlateletsReactive Oxygen SpeciesPlatelet Activation

Outcome Measures

Primary Outcomes (1)

  • Leukocyte radical oxygen species (ROS) production

    24 hours for each crossover event

Secondary Outcomes (1)

  • Platelet activation status

    24 hours for each crossover event

Study Arms (4)

Ibuprofen 400 mg

ACTIVE COMPARATOR

Ibuprofen oral single dose

Drug: Ibuprofen

Ibuprofen 1200 mg

ACTIVE COMPARATOR

Ibuprofen oral single dose

Drug: Ibuprofen

Paracetamol (acetaminophen) 1000 mg

ACTIVE COMPARATOR

Paracetamol (acetaminophen) oral single dose

Drug: Paracetamol (acetaminophen) 1000 mg

Ibuprofen 400 mg + paracetamol 1000 mg

ACTIVE COMPARATOR

Paracetamol (acetaminophen) + ibuprofen oral single dose

Drug: Paracetamol + ibuprofen

Interventions

IbuprofenDRUG

Tablet ibuprofen 400 mg oral single dose (1 tablet)

Also known as: Ibumetin, ATC code: M01A E01
Ibuprofen 400 mg
Paracetamol (acetaminophen) 1000 mgDRUG

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

Also known as: Paracetamol, Acetaminophen, ATC code: N02B E01
Paracetamol (acetaminophen) 1000 mg
Paracetamol + ibuprofenDRUG

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

Also known as: Ibumetin, Ibuprofen, ATC code: M01A E01, Paracetamol, Acetaminophen, ATC code: N02B E01
Ibuprofen 400 mg + paracetamol 1000 mg

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy during the test period.
  • Development of active peptic ulcer during the test period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ullevaal University Hospital

Oslo, NO-0407, Norway

Location

Related Publications (3)

  • 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.

    PMID: 16891997BACKGROUND

  • Nagata M. Inflammatory cells and oxygen radicals. Curr Drug Targets Inflamm Allergy. 2005 Aug;4(4):503-4. doi: 10.2174/1568010054526322.

    PMID: 16101529BACKGROUND

  • Nielsen VG, Webster RO. Inhibition of human polymorphonuclear leukocyte functions by ibuprofen. Immunopharmacology. 1987 Feb;13(1):61-71. doi: 10.1016/0162-3109(87)90027-0.

    PMID: 3032852BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

IbuprofenAcetaminophen

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAcetanilidesAnilidesAmidesAniline CompoundsAmines

Study Officials

  • Torstein Lyberg, DDS, MD

    Ullevaal University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 15, 2009

First Posted

June 16, 2009

Study Start

May 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

July 6, 2011

Record last verified: 2009-03

Locations

NO(1)