Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-02-24 @ 8:51 AM
Study NCT ID:
NCT02531451
Status:
COMPLETED
Last Update Posted:
2016-06-28
First Post:
2015-08-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of COX-inhibiting Drugs on Skeletal Muscle Adaptations to Resistance Exercise in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007052', 'term': 'Ibuprofen'}, {'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-27', 'studyFirstSubmitDate': '2015-08-19', 'studyFirstSubmitQcDate': '2015-08-21', 'lastUpdatePostDateStruct': {'date': '2016-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Quadriceps muscle volume', 'timeFrame': 'Baseline and after 8 weeks training', 'description': 'Measured through MRI'}], 'secondaryOutcomes': [{'measure': 'Change in muscle gene expression', 'timeFrame': 'Baseline, 4 weeks and after 8 weeks training', 'description': 'Through quantitative PCR and microarray'}, {'measure': 'Change in muscle protein expression', 'timeFrame': 'Baseline, 4 weeks and after 8 weeks training', 'description': 'Through Western Blots'}, {'measure': 'Change in Quadriceps muscle strength', 'timeFrame': 'Baseline and after 8 weeks training', 'description': 'Measured in strength dynamometers'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Muscle mass', 'strength', 'NSAID', 'Ibuprofen', 'resistance exercise'], 'conditions': ['Skeletal Muscle Mass Regulation']}, 'descriptionModule': {'briefSummary': 'In this study, healthy human subjects (18-35 yrs) are be randomised to consume 1200 mg ibuprofen or 75 mg acetylsalicylic acid daily during a training period of 8 weeks. During these weeks, subjects perform 2-3 supervised strength training sessions (knee extensions). Before and after training, muscle volume is measured by MRI, and muscle strength is assessed by isokinetic and isoinertial ergometers. Muscle biopsies are obtained from m. vastus lateralis to study gene and protein expression of markers regulating muscle protein turnover and prostaglandin synthesis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Considered healthy\n* Moderately trained\n* 18-35 yrs\n\nExclusion Criteria:\n\n* Cardiovascular disease\n* Impaired kidney or liver function\n* Lower limb injury\n* Pregnancy\n* Ulcer or gastrointestinal upsets\n* Previous reactions to use of NSAID'}, 'identificationModule': {'nctId': 'NCT02531451', 'acronym': 'NSAID2015', 'briefTitle': 'The Effects of COX-inhibiting Drugs on Skeletal Muscle Adaptations to Resistance Exercise in Healthy Adults', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'The Effects of COX-inhibiting Drugs on Skeletal Muscle Adaptations to Resistance Exercise', 'orgStudyIdInfo': {'id': '2014-004872-47'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ibuprofen', 'description': 'Resistance exercise 20 sessions during 8 weeks Daily consumption of 1200 mg ibuprofen (400 mg x 3) during 8 weeks', 'interventionNames': ['Drug: Ibuprofen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Acetylsalicylic acid', 'description': 'Resistance exercise 20 sessions during 8 weeks Daily consumption of 75 mg acetylsalicylic acid (75 mg x 1) during 8 weeks', 'interventionNames': ['Drug: Acetylsalicylic acid']}], 'interventions': [{'name': 'Ibuprofen', 'type': 'DRUG', 'armGroupLabels': ['Ibuprofen']}, {'name': 'Acetylsalicylic acid', 'type': 'DRUG', 'armGroupLabels': ['Acetylsalicylic acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14186', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Institutet', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Tommy Lundberg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Tommy Lundberg', 'investigatorAffiliation': 'Karolinska Institutet'}}}}