PainPhase 4NCT00921505
Effect of Ibuprofen, Paracetamol and Their Combination on Radical Oxygen Species (ROS) Production
A Phase 4 study testing Ibuprofen, Paracetamol (acetaminophen) 1000 mg and Paracetamol + ibuprofen in people with Pain, run by Ullevaal University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Pain
- What is being tested?
- Ibuprofen, Paracetamol (acetaminophen) 1000 mg and Paracetamol + ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteNorway
- Study dates
- May 2009to Jan 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Pregnancy during the test period.
- Development of active peptic ulcer during the test period.
- Change in medication status during the test period (after inclusion).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Also called Ibumetin, ATC code: M01A E01
Tablet ibuprofen 400 mg oral single dose (1 tablet)
IbuprofenDrug
Also called Ibumetin, ATC code: M01A E01
Tablets (2 x 600 mg) oral single dose (2 tablets)
Paracetamol (acetaminophen) 1000 mgDrug
Also called Paracetamol, Acetaminophen, ATC code: N02B E01
Tablets (2 x 500 mg) oral single dose (2 tablets)
Paracetamol + ibuprofenDrug
Also called Ibumetin, Ibuprofen, ATC code: M01A E01, Paracetamol
Tablets (ibuprofen 400 mg + paracetamol (acetaminophen) 2 x 500 mg) single oral dose (3 tablets)
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen 400 mg | Active comparator | Ibuprofen oral single dose Receives: Drug: Ibuprofen |
| Ibuprofen 1200 mg | Active comparator | Ibuprofen oral single dose Receives: Drug: Ibuprofen |
| Paracetamol (acetaminophen) 1000 mg | Active comparator | Paracetamol (acetaminophen) oral single dose Receives: Drug: Paracetamol (acetaminophen) 1000 mg |
| Ibuprofen 400 mg + paracetamol 1000 mg | Active comparator | Paracetamol (acetaminophen) + ibuprofen oral single dose Receives: Drug: Paracetamol + ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leukocyte radical oxygen species (ROS) production
Measured: 24 hours for each crossover event
Secondary outcomes (1)
Platelet activation status
Measured: 24 hours for each crossover event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Investigators
- Torstein Lyberg, DDS, MD, Study director, Ullevaal University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921505
- Sponsor's protocol ID
- PARIBU-024
- Other IDs
- EudraCT No. 2009-009036-77
- Status last verified
- Mar 2009
- First submitted
- 15 Jun 2009
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16891997Nagata M. Inflammatory cells and oxygen radicals. Curr Drug Targets Inflamm Allergy. 2005 Aug;4(4):503-4. doi: 10.2174/1568010054526322.
PubMed 16101529Nielsen 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.
PubMed 3032852
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ibuprofen, Paracetamol and Their Combination on Reactive Oxygen Species (ROS)- Production in Leukocytes and Platelet Activation
- ClinicalTrials.gov ID
- NCT00921505
- Acronym / sponsor ID
- PARIBU-024
- Conditions
- Pain
- Keywords
- Acetaminophen, Ibuprofen, Platelets, Leukocytes, Oxygen species, Humans, Blood Platelets, Reactive Oxygen Species
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- May 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 16 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen 400 mg | Active comparator | Drug: IbuprofenIbuprofen oral single dose |
| Ibuprofen 1200 mg | Active comparator | Drug: IbuprofenIbuprofen oral single dose |
| Paracetamol (acetaminophen) 1000 mg | Active comparator | Drug: Paracetamol (acetaminophen) 1000 mgParacetamol (acetaminophen) oral single dose |
| Ibuprofen 400 mg + paracetamol 1000 mg | Active comparator | Drug: Paracetamol + ibuprofenParacetamol (acetaminophen) + ibuprofen oral single dose |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- Pregnancy during the test period.
- Development of active peptic ulcer during the test period.
- Change in medication status during the test period (after inclusion).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbuprofenAlso: Ibumetin, ATC code: M01A E01Tablet ibuprofen 400 mg oral single dose (1 tablet) | Drug | Ibuprofen 400 mg |
| IbuprofenAlso: Ibumetin, ATC code: M01A E01Tablets (2 x 600 mg) oral single dose (2 tablets) | Drug | Ibuprofen 1200 mg |
| Paracetamol (acetaminophen) 1000 mgAlso: Paracetamol, Acetaminophen, ATC code: N02B E01Tablets (2 x 500 mg) oral single dose (2 tablets) | Drug | Paracetamol (acetaminophen) 1000 mg |
| Paracetamol + ibuprofenAlso: Ibumetin, Ibuprofen, ATC code: M01A E01, ParacetamolTablets (ibuprofen 400 mg + paracetamol (acetaminophen) 2 x 500 mg) single oral dose (3 tablets) | Drug | Ibuprofen 400 mg + paracetamol 1000 mg |
Primary outcome
Leukocyte radical oxygen species (ROS) production
Time frame: 24 hours for each crossover event
1 secondary outcome
Platelet activation status
Time frame: 24 hours for each crossover event
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2011.
- Background: PubMed 16891997Stritesky Larssen K, Lyberg T. Oxidative status--age- and circadian variations?--a study in leukocytes/plasma. Neuro Endocrinol Lett. 2006 Aug;27(4):445-52.
- Background: PubMed 16101529Nagata M. Inflammatory cells and oxygen radicals. Curr Drug Targets Inflamm Allergy. 2005 Aug;4(4):503-4. doi: 10.2174/1568010054526322.
- Background: PubMed 3032852Nielsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torstein Lyberg, DDS, MD study director
Ullevaal University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ibuprofen, Paracetamol (acetaminophen) 1000 mg and Paracetamol + ibuprofen in people with Pain, run by Ullevaal University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leukocyte radical oxygen species (ROS) production (time frame: 24 hours for each crossover event). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00921505, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2011.