Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-02-26 @ 5:44 PM
Study NCT ID:
NCT01893905
Status:
COMPLETED
Last Update Posted:
2017-08-04
First Post:
2013-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of a New Formulation of Chondroitin Sulfate and Glucosamine Sulfate to Treat Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fblagar@sergas.es', 'phone': '981 17 80 00', 'title': 'Dr Francisco Blanco, study coordinator', 'organization': 'Complejo Hospitalario de La Coruña (CHUAC)'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'CS+SG', 'description': 'chondroitin sulfate+glucosamine sulfate', 'otherNumAtRisk': 80, 'otherNumAffected': 20, 'seriousNumAtRisk': 80, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo oral', 'otherNumAtRisk': 78, 'otherNumAffected': 18, 'seriousNumAtRisk': 78, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'seriousEvents': [{'term': 'Breast cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Pain According to VAS (0-100 mm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CS+SG', 'description': 'Chondroitin sulfate+glucosamine sulfate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Oral'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.86', 'spread': '2.42', 'groupId': 'OG000'}, {'value': '-20.57', 'spread': '2.41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0307', 'groupIds': ['OG001'], 'statisticalMethod': 'Pocock approach', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'VAS=The visual analogue scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, the patients specify their condition by indicating a position along a continuous line between two end-points. In our case a 0-100 mm line was used to define the degree of pain. The change between baseline and each evaluation visit (week 4, week 12 and week 24) was calculated to evaluate the efficacy of the treatments (a negative number represents a decrease in pain).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CS+SG', 'description': 'Chondroitin sulfate+ glucosamine sulfate'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Oral Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '78'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of adherence to treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CS+SG', 'description': 'Chondroitin sulfate+glucosamine sulfate'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo oral'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.49', 'spread': '8.17', 'groupId': 'BG000'}, {'value': '67.60', 'spread': '8.90', 'groupId': 'BG001'}, {'value': '66.53', 'spread': '8.58', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-25', 'studyFirstSubmitDate': '2013-07-02', 'resultsFirstSubmitDate': '2016-12-22', 'studyFirstSubmitQcDate': '2013-07-02', 'lastUpdatePostDateStruct': {'date': '2017-08-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-25', 'studyFirstPostDateStruct': {'date': '2013-07-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain According to VAS (0-100 mm)', 'timeFrame': '24 weeks', 'description': 'VAS=The visual analogue scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, the patients specify their condition by indicating a position along a continuous line between two end-points. In our case a 0-100 mm line was used to define the degree of pain. The change between baseline and each evaluation visit (week 4, week 12 and week 24) was calculated to evaluate the efficacy of the treatments (a negative number represents a decrease in pain).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '27477804', 'type': 'DERIVED', 'citation': 'Roman-Blas JA, Castaneda S, Sanchez-Pernaute O, Largo R, Herrero-Beaumont G; CS/GS Combined Therapy Study Group. Combined Treatment With Chondroitin Sulfate and Glucosamine Sulfate Shows No Superiority Over Placebo for Reduction of Joint Pain and Functional Impairment in Patients With Knee Osteoarthritis: A Six-Month Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Arthritis Rheumatol. 2017 Jan;69(1):77-85. doi: 10.1002/art.39819.'}]}, 'descriptionModule': {'briefSummary': 'The main objective is to assess the efficacy of a new formulation containing chondroitin sulfate and glucosamine sulfate (CS+GS) compared with placebo in patients with primary osteoarthritis of the knee.', 'detailedDescription': 'The purpose of this study is to determine whether a new combination of chondroitin sulfate and glucosamine sulfate administered once a day is superior to placebo in the treatment of patients with moderate to severe knee osteoarthritis. Eligible patients will be randomized 1:1 and the treatments will be administered for 24 weeks. Clinical efficacy at the end of treatment will be evaluated. Safety will be evaluated through adverse events recoding during the study period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient \\>= 45 years .\n* Primary OA of the knee according to ACR criteria.\n* OA radiological grade II-III according to Kellgren and Lawrence.\n* Patients with moderate-severe pain.\n\nExclusion Criteria:\n\n* Patients with clinical significant trauma or surgery in the target knee.\n* Concurrent arthritic disease (antecedents and/or current signs) that could confound or interfere with the evaluation of pain efficacy such as chondrocalcinosis, Paget's disease of the ipsilateral limb to the target knee, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, haemochromatosis, Wilson's disease, osteochondromatosis, seronegative spondyloarthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis, inflammatory bowel disease or fibromyalgia.\n* Pain in other parts of the body greater than the knee pain that could interfere with the evaluation.\n* Subjects with any active acute or chronic infections requiring antimicrobial therapy, or serious viral (e.g., hepatitis, herpes zoster, HIV positivity) or fungal infections.\n* Clinical diagnosis established of uncontrolled diabetes mellitus.\n* Patients with asthma.\n* History of hypersensitivity to the active drugs or any excipients of the formulations."}, 'identificationModule': {'nctId': 'NCT01893905', 'briefTitle': 'Efficacy and Safety of a New Formulation of Chondroitin Sulfate and Glucosamine Sulfate to Treat Knee Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tedec-Meiji Farma, S.A.'}, 'officialTitle': 'Phase III Clinical Trial to Evaluate the Efficacy and Safety of Chondroitin Sulfate and Glucosamine Sulfate in Combination Versus Placebo in Patients With Osteoarthritis of the Knee', 'orgStudyIdInfo': {'id': 'TM-CS+SG /301'}, 'secondaryIdInfos': [{'id': '2013-000444-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CS+SG', 'description': 'Chondroitin sulfate 1200mg+ glucosamine sulfate 1500mg orally administered once a day for 24 weeks', 'interventionNames': ['Drug: CS+SG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo of chondroitin sulfate + glucosamine sulfate orally administered once a day for 24 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CS+SG', 'type': 'DRUG', 'otherNames': ['Chondroitin sulfate+glucosamine sulfate'], 'description': 'Chondroitin sulfate+glucosamine sulfate orally administered once a day for 24 weeks.', 'armGroupLabels': ['CS+SG']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo chondroitin sulfate+glucosamine sulfate'], 'description': 'Placebo of chondroitin sulfate+glucosamine sulfate orally administered once a day for 24 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15006', 'city': 'A Coruña', 'state': 'La Coruña', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario La Coruña', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}], 'overallOfficials': [{'name': 'FJ Blanco, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Complejo Hospitalario Universitario La Coruña'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tedec-Meiji Farma, S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}