Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-30 @ 4:19 PM
Study NCT ID:
NCT01836757
Status:
UNKNOWN
Last Update Posted:
2013-04-22
First Post:
2013-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Methyl-Sulphonyl-Methane on Osteoarthritis and Cartilage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C025910', 'term': 'dimethyl sulfone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-04-17', 'studyFirstSubmitDate': '2013-03-13', 'studyFirstSubmitQcDate': '2013-04-17', 'lastUpdatePostDateStruct': {'date': '2013-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with improved Mobility', 'timeFrame': '26 weeks', 'description': 'Randomized, double-blind, placebo-controlled trial including an intervention and a placebo group. One hundred men and women, with hip and/or knee OA were divided in 2 groups. Intervention was either MSM 3 gr twice a day for 26 weeks (6 gr/day total) for one group and placebo for the other. Outcomes measured were the Western Ontario and McMaster University Osteoarthritis Index visual analogue scale (WOMAC)'}], 'secondaryOutcomes': [{'measure': 'Pain Scores on the Visual Analog Scale', 'timeFrame': '26 weeks', 'description': 'On the same two groups (MSM and Placebo)we measured the improvement of quality of life through pain relief as measured by use of SF-36 (overall health-related quality of life)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['osteoarthritis', 'CAM treatments', 'MSM'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'To delineate the effect of MSM on osteoarthritis', 'detailedDescription': 'Objective: To delineate the effect of MSM on osteoarthritis of large joints. Design: Randomized, double-blind, placebo-controlled trial including an intervention and a placebo group. One hundred men and women, with hip and/or knee OA to be divided in 2 groups. Intervention is either MSM 3 gr twice a day for 26 weeks (6 gr/day total) for one group and placebo for the other. Outcomes measured are the Western Ontario and McMaster University Osteoarthritis Index visual analogue scale (WOMAC), patient and physician assessments and SF-36 (overall health-related quality of life).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Knee and hip OA\n* men and women \\>45 years of age\n\nExclusion Criteria:\n\n* any other type of arthritis\n* chronic pain syndrome\n* arthroscopic surgery in the past 8 months\n* intra-articular corticosteroidsin the past 8 months\n* hyaluronic acid injections in the past 8 months\n* narcotic pain killers use\n* renal or hepatic disease\n* body mass index (BMI) \\>45 kg/m2\n* cancer'}, 'identificationModule': {'nctId': 'NCT01836757', 'acronym': 'msm', 'briefTitle': 'Effect of Methyl-Sulphonyl-Methane on Osteoarthritis and Cartilage', 'organization': {'class': 'OTHER', 'fullName': 'G.Papanikolaou Research Group'}, 'officialTitle': 'The Effect of Methyl-Sulphonyl-Methane on Osteoarthritis and Joint Cartilage Associated With the Degeneration of the Chondrocyte', 'orgStudyIdInfo': {'id': 'msm2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MSM group', 'description': 'Intervention is MSM 3 gr twice a day for 26 weeks (6 gr/day total)', 'interventionNames': ['Drug: MethylSulfonylMethane (MSM)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Placebo 3 gr twice a day for 26 weeks (6 gr/day total)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'MethylSulfonylMethane (MSM)', 'type': 'DRUG', 'description': 'Intervention is MSM 3 gr twice a day for 26 weeks (6 gr/day total)', 'armGroupLabels': ['MSM group']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57010', 'city': 'Thessaloniki', 'state': 'Thessaloniki', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Panagiotis Givisis, MD, PhD', 'role': 'CONTACT', 'phone': '00306945264010'}, {'name': 'Thomas Pagonis, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'G. Papanikolaou Hospital', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'centralContacts': [{'name': 'Thomas Pagonis, MD, PhD', 'role': 'CONTACT', 'email': 'iatros1@yahoo.com', 'phone': '00306980488686'}], 'overallOfficials': [{'name': 'Thomas Pagonis, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Aristotle's University of Thessaloniki"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'G.Papanikolaou Research Group', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Orthopaedic Surgeon', 'investigatorFullName': 'Thomas Pagonis', 'investigatorAffiliation': 'G.Papanikolaou Research Group'}}}}