Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-25 @ 4:28 PM
Study NCT ID:
NCT00833157
Status:
UNKNOWN
Last Update Posted:
2009-01-30
First Post:
2009-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Glucosamine or Ibuprofen Combined With Physical Training in Patients With Knee-Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005944', 'term': 'Glucosamine'}, {'id': 'D007052', 'term': 'Ibuprofen'}], 'ancestors': [{'id': 'D006595', 'term': 'Hexosamines'}, {'id': 'D000606', 'term': 'Amino Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2009-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-01-29', 'studyFirstSubmitDate': '2009-01-29', 'studyFirstSubmitQcDate': '2009-01-29', 'lastUpdatePostDateStruct': {'date': '2009-01-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'muscle strength and hypertrophy', 'timeFrame': 'We measure before and after 12-weeks strength training.'}, {'measure': 'cartilage biomarkers', 'timeFrame': 'We measure before and after 12 weeks strength training'}], 'secondaryOutcomes': [{'measure': 'muscle regeneration and function', 'timeFrame': 'We measure before and after 12-weeks strength training.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Knee Osteoarthritis', 'exercise', 'strength training', 'Glucosamine', 'Dietary supplement', 'Ibuprofen', 'NSAID'], 'conditions': ['Osteoarthritis of the Knee']}, 'referencesModule': {'references': [{'pmid': '21807137', 'type': 'DERIVED', 'citation': 'Petersen SG, Beyer N, Hansen M, Holm L, Aagaard P, Mackey AL, Kjaer M. Nonsteroidal anti-inflammatory drug or glucosamine reduced pain and improved muscle strength with resistance training in a randomized controlled trial of knee osteoarthritis patients. Arch Phys Med Rehabil. 2011 Aug;92(8):1185-93. doi: 10.1016/j.apmr.2011.03.009.'}, {'pmid': '19679221', 'type': 'DERIVED', 'citation': 'Petersen SG, Saxne T, Heinegard D, Hansen M, Holm L, Koskinen S, Stordal C, Christensen H, Aagaard P, Kjaer M. Glucosamine but not ibuprofen alters cartilage turnover in osteoarthritis patients in response to physical training. Osteoarthritis Cartilage. 2010 Jan;18(1):34-40. doi: 10.1016/j.joca.2009.07.004. Epub 2009 Jul 15.'}]}, 'descriptionModule': {'briefSummary': 'The investigators will investigate the effect of glucosamine or ibuprofen combined with 12 weeks of muscle strength-training in patients with knee-osteoarthritis.\n\nThe investigators would like to elucidate whether treatment with glucosamine or NSAID interact with the effects of exercise in osteoarthritis patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 50 to 70 years\n* Bilateral tibiofemoral osteoarthritis of the knee on x-ray\n* American College of Rheumatology (ACR) clinical classification criteria\n\nExclusion Criteria:\n\n* Severe health problems such as cardiovascular disease, active cancer, diabetes, kidney or liver diseases\n* Excess alcohol use (\\> 21 alcoholic drinks per week)\n* Severe overweight (BMI \\> 35)\n* History of injury or operation in the knee, planned knee-joint replacement, other rheumatologic diseases, previous gastric ulcer, allergy to the contents of ibuprofen or glucosamine, regular strength training prior to the inclusion'}, 'identificationModule': {'nctId': 'NCT00833157', 'briefTitle': 'Effect of Glucosamine or Ibuprofen Combined With Physical Training in Patients With Knee-Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'Effect of Glucosamine or Ibuprofen Combined With Physical Training in Patients With Knee-Osteoarthritis', 'orgStudyIdInfo': {'id': 'HIM-037'}, 'secondaryIdInfos': [{'id': 'KF-01-18904'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glucosamine', 'interventionNames': ['Drug: glucosamine sulphate']}, {'type': 'EXPERIMENTAL', 'label': 'Ibuprofen', 'interventionNames': ['Drug: ibuprofen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'glucosamine sulphate', 'type': 'DRUG', 'otherNames': ['glucosamine from Ferrosan'], 'description': 'Subjects are administered glucosamine-sulphate tablets of 500 mg \\* 3 daily, while they are performing a strength-training program with both legs (\\*3 weekly) for 12 weeks.', 'armGroupLabels': ['Glucosamine']}, {'name': 'ibuprofen', 'type': 'DRUG', 'otherNames': ['"Ibumetin" from Nycomed (vnr:38 83 71)'], 'description': 'Subjects are administered 600 mg \\* 2 daily, while they are performing a strength-training program with both legs (\\*3 weekly) for 12 weeks', 'armGroupLabels': ['Ibuprofen']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Subjects are administered placebo tablets, while they are performing a strength-training program (\\*3 weekly) with both legs for 12 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Susanne G Petersen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bispebjerg Hospital, Institute of Sports Medicine Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lund University', 'class': 'OTHER'}, {'name': 'The Danish Rheumatism Association', 'class': 'OTHER'}, {'name': 'Ministry of the Interior and Health, Denmark', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Susanne G. Petersen, doctor', 'oldOrganization': 'Institute of Sports Medicine Copenhagen, Bispebjerg Hospital, Denmark'}}}}