Effect of Ibuprofen, Paracetamol and Their Combination on Radical Oxygen Species (ROS) Production
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|ClinicalTrials.gov Identifier: NCT00921505|
Recruitment Status : Completed
First Posted : June 16, 2009
Last Update Posted : July 6, 2011
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|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Ibuprofen Drug: Paracetamol (acetaminophen) 1000 mg Drug: Paracetamol + ibuprofen||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||7 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||The Effect of Ibuprofen, Paracetamol and Their Combination on Reactive Oxygen Species (ROS)- Production in Leukocytes and Platelet Activation|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
Active Comparator: Ibuprofen 400 mg
Ibuprofen oral single dose
Tablet ibuprofen 400 mg oral single dose (1 tablet)
Active Comparator: Ibuprofen 1200 mg
Ibuprofen oral single dose
Tablets (2 x 600 mg) oral single dose (2 tablets)
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)
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)
- Leukocyte radical oxygen species (ROS) production [ Time Frame: 24 hours for each crossover event ]
- Platelet activation status [ Time Frame: 24 hours for each crossover event ]
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|Ages Eligible for Study:||18 Years to 35 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- Pregnancy during the test period.
- Development of active peptic ulcer during the test period.
- Change in medication status during the test period (after inclusion).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00921505
|Ullevaal University Hospital|
|Oslo, Norway, NO-0407|
|Study Director:||Torstein Lyberg, DDS, MD||Ullevaal University Hospital|
|Responsible Party:||Professor Torstein Lyberg, Ullevaal University Hospital|
|Other Study ID Numbers:||
EudraCT No. 2009-009036-77
|First Posted:||June 16, 2009 Key Record Dates|
|Last Update Posted:||July 6, 2011|
|Last Verified:||March 2009|
Reactive Oxygen Species
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Molecular Mechanisms of Pharmacological Action