Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-01-01 @ 4:02 AM
Study NCT ID:
NCT00921505
Status:
COMPLETED
Last Update Posted:
2011-07-06
First Post:
2009-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Ibuprofen, Paracetamol and Their Combination on Radical Oxygen Species (ROS) Production
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007052', 'term': 'Ibuprofen'}, {'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-03', 'studyFirstSubmitDate': '2009-06-15', 'studyFirstSubmitQcDate': '2009-06-15', 'lastUpdatePostDateStruct': {'date': '2011-07-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Leukocyte radical oxygen species (ROS) production', 'timeFrame': '24 hours for each crossover event'}], 'secondaryOutcomes': [{'measure': 'Platelet activation status', 'timeFrame': '24 hours for each crossover event'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acetaminophen', 'Ibuprofen', 'Platelets', 'Leukocytes', 'Oxygen species', 'Humans', 'Blood Platelets', 'Reactive Oxygen Species', 'Platelet Activation'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '16891997', 'type': 'BACKGROUND', 'citation': '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': '16101529', 'type': 'BACKGROUND', 'citation': 'Nagata M. Inflammatory cells and oxygen radicals. Curr Drug Targets Inflamm Allergy. 2005 Aug;4(4):503-4. doi: 10.2174/1568010054526322.'}, {'pmid': '3032852', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteers of both sexes (ASA type I).\n* Females who are not pregnant or plan conception. (A pregnancy test will be conducted before each test day)\n* Persons who have not used analgesics for 3 days prior to the blood sampling.\n* Persons without known active peptic ulcer or gastrointestinal bleeding.\n* Persons without any known hypersensitivity for NSAIDs.\n* Persons under no other drug treatment than contraceptives.\n* Age 18 to 35 years of Caucasian origin\n\nExclusion Criteria:\n\n* Pregnancy during the test period.\n* Development of active peptic ulcer during the test period.\n* Change in medication status during the test period (after inclusion).'}, 'identificationModule': {'nctId': 'NCT00921505', 'briefTitle': 'Effect of Ibuprofen, Paracetamol and Their Combination on Radical Oxygen Species (ROS) Production', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'The Effect of Ibuprofen, Paracetamol and Their Combination on Reactive Oxygen Species (ROS)- Production in Leukocytes and Platelet Activation', 'orgStudyIdInfo': {'id': 'PARIBU-024'}, 'secondaryIdInfos': [{'id': 'EudraCT No. 2009-009036-77'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ibuprofen 400 mg', 'description': 'Ibuprofen oral single dose', 'interventionNames': ['Drug: Ibuprofen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ibuprofen 1200 mg', 'description': 'Ibuprofen oral single dose', 'interventionNames': ['Drug: Ibuprofen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Paracetamol (acetaminophen) 1000 mg', 'description': 'Paracetamol (acetaminophen) oral single dose', 'interventionNames': ['Drug: Paracetamol (acetaminophen) 1000 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ibuprofen 400 mg + paracetamol 1000 mg', 'description': 'Paracetamol (acetaminophen) + ibuprofen oral single dose', 'interventionNames': ['Drug: Paracetamol + ibuprofen']}], 'interventions': [{'name': 'Ibuprofen', 'type': 'DRUG', 'otherNames': ['Ibumetin', 'ATC code: M01A E01'], 'description': 'Tablet ibuprofen 400 mg oral single dose (1 tablet)', 'armGroupLabels': ['Ibuprofen 400 mg']}, {'name': 'Ibuprofen', 'type': 'DRUG', 'otherNames': ['Ibumetin', 'ATC code: M01A E01'], 'description': 'Tablets (2 x 600 mg) oral single dose (2 tablets)', 'armGroupLabels': ['Ibuprofen 1200 mg']}, {'name': 'Paracetamol (acetaminophen) 1000 mg', 'type': 'DRUG', 'otherNames': ['Paracetamol', 'Acetaminophen', 'ATC code: N02B E01'], 'description': 'Tablets (2 x 500 mg) oral single dose (2 tablets)', 'armGroupLabels': ['Paracetamol (acetaminophen) 1000 mg']}, {'name': 'Paracetamol + ibuprofen', 'type': 'DRUG', 'otherNames': ['Ibumetin', 'Ibuprofen', 'ATC code: M01A E01', 'Paracetamol', 'Acetaminophen', 'ATC code: N02B E01'], 'description': 'Tablets (ibuprofen 400 mg + paracetamol (acetaminophen) 2 x 500 mg) single oral dose (3 tablets)', 'armGroupLabels': ['Ibuprofen 400 mg + paracetamol 1000 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NO-0407', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Ullevaal University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Torstein Lyberg, DDS, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ullevaal University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ullevaal University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Oslo', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Professor Torstein Lyberg', 'oldOrganization': 'Ullevaal University Hospital'}}}}