Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-03-07 @ 4:28 PM
Study NCT ID:
NCT02010918
Status:
COMPLETED
Last Update Posted:
2013-12-13
First Post:
2013-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Glucosamine Sulfate and Chondroitin Sulfate Combination in Treatment of Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005944', 'term': 'Glucosamine'}, {'id': 'D002809', 'term': 'Chondroitin Sulfates'}], 'ancestors': [{'id': 'D006595', 'term': 'Hexosamines'}, {'id': 'D000606', 'term': 'Amino Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D002807', 'term': 'Chondroitin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 922}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-10', 'studyFirstSubmitDate': '2013-07-19', 'studyFirstSubmitQcDate': '2013-12-10', 'lastUpdatePostDateStruct': {'date': '2013-12-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants with Serious and Non-Serious Adverse Events', 'timeFrame': 'baseline, week 16'}], 'primaryOutcomes': [{'measure': "Change from baseline in pain intensity in the affected knee and variation of Lequesne's index and VAS at week 16 .", 'timeFrame': 'BASELINE, week 16'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants with any Decrease in Pain Visual Analogue Scale (VAS)', 'timeFrame': 'baseline, week 16'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Knee Osteoarthritis;', 'Glucosamine;', 'Chondroitin.'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether 500 mg Glucosamine Sulfate / 400 mg Chondroitin Sulfate Capsules and 1500 mg Glucosamine Sulfate / 1200 mg Chondroitin Sulfate Sachet is effective and safe compared Cosamin DS ® Capsule in Treatment of Knee Osteoarthritis.', 'detailedDescription': 'The Groups receive treatment for 16 weeks. The study is realized in 16 sites in Brazil.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patient, older than 40 years of age, with knee osteoarthritis, based on clinical and radiological criteria (Kellgren-Lawrence grade 2 - 3), as specified:\n\n 1. Pain on movement of the affected knee for more than 15 days in the previous month with at least partial relief at rest;\n 2. Presence of osteophytes at least 1 mm in radiological imaging;\n* Knee osteoarthritis symptoms for at least six months prior to randomization.\n\nExclusion Criteria:\n\n* Concomitant arthropathy that may confuse or interfere with assessing the efficacy or pain;\n* Patellar disease isolated, with primary symptoms of pain in the anterior knee, in the absence of radiological findings already described;\n* History of significant injury on collateral ligament, or anterior cruciate, or meniscus of the joint studied, with surgery, or immobilization for at least 3 weeks;\n* Arthroscopy of the affected knee in last 6 months;\n* Serum creatinine ≥ 1.8 mg/dL;\n* Diagnosis of diabetes mellitus;\n* Presence of any serious disease that could compromise the study, at the investigator discretion;\n* History of adverse event or allergy to acetaminophen, glucosamine sulfate or chondroitin sulfate;\n* Inability to understand and report the study questionnaire and the Visual Analogic Scale;\n* Inability to understand and consent to participate in this clinical study, expressed by signing the Informed Consent (IC);\n* Woman in pregnancy.\n* If female of childbearing potential, has a negative urine pregnancy test at Visit 0 and do not use, or do not agree to use, for the duration of the study, a medically acceptable form of contraception as determined by the investigator;\n* Alcohol intake ( \\> 3 doses/day);\n* Oral or intramuscular corticosteroids four weeks prior to study entry;\n* Intra-articular injections with corticosteroids, into the studied knee, within the past three months;\n* Intra-articular injections in any other joint within the past four weeks;\n* NSAID users that don´t respect the washout period. Low-dose aspirin (325 mg or less, once daily) is allowed for cardio-protective benefit;\n* Intra-articular injections of hyaluronic acid within the past 12 months;\n* Use of topical analgesic in the joint studied or any other oral analgesic (with the exception of acetaminophen and other NSAID) two weeks prior to randomization;\n* Implementation of any other medical treatment for osteoarthritis one month prior to study entry;\n* Participation in last one year of clinical protocols, unless it can be direct benefit to patient;\n* Use of glucosamine and/or chondroitin sulfate three and six months prior the study entry, respectively;\n* Initiation of physical therapy two months prior to the study period;\n* Use of tetracycline and oral anticoagulants;\n* Use of vitamin D in doses in doses above the recommended;\n* Patients in alternative therapies;\n* Allergy to sulfonamides;\n* Presence of psychiatric disorders that could compromise the study.'}, 'identificationModule': {'nctId': 'NCT02010918', 'briefTitle': 'Efficacy and Safety of Glucosamine Sulfate and Chondroitin Sulfate Combination in Treatment of Knee Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ache Laboratorios Farmaceuticos S.A.'}, 'officialTitle': 'A Phase III, Multicenter, Randomized, Parallel, Open Label and Comparative Study to Evaluate the Efficacy of 500 mg Glucosamine Sulfate (GS) / 400 mg Chondroitin Sulfate (CS)Capsules and 1500 mg GS / 1200 mg CS Sachet Compared With Cosamin DS® Capsule in Treatment of Knee Osteoarthritis..', 'orgStudyIdInfo': {'id': 'ACH-ART-03(01/08)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'glucosamine sulfate /chondroitin sulfate capsule', 'description': '500 mg glucosamine sulfate + 400 mg chondroitin sulfate - capsules; One capsule, three times daily.', 'interventionNames': ['Drug: glucosamine sulfate /chondroitin sulfate - capsules']}, {'type': 'EXPERIMENTAL', 'label': 'glucosamine sulfate /chondroitin sulfate - sachet', 'description': '1500 mg glucosamine sulfate / 1200 mg chondroitin sulfate - sachet; One sachet preparation, once daily.', 'interventionNames': ['Drug: glucosamine sulfate /chondroitin sulfate - sachet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cosamin DS®', 'description': '500 mg glucosamine hydrochloride + 400 mg chondroitin sulfate - Capsules; One capsule, three times daily.', 'interventionNames': ['Drug: Cosamin DS®']}], 'interventions': [{'name': 'glucosamine sulfate /chondroitin sulfate - capsules', 'type': 'DRUG', 'description': '500 mg glucosamine sulfate + 400 mg chondroitin sulfate - capsules; One capsule, three times daily.', 'armGroupLabels': ['glucosamine sulfate /chondroitin sulfate capsule']}, {'name': 'glucosamine sulfate /chondroitin sulfate - sachet', 'type': 'DRUG', 'description': '1500 mg glucosamine sulfate / 1200 mg chondroitin sulfate - sachet; One sachet preparation, once daily.', 'armGroupLabels': ['glucosamine sulfate /chondroitin sulfate - sachet']}, {'name': 'Cosamin DS®', 'type': 'DRUG', 'description': '500 mg glucosamine hydrochloride + 400 mg chondroitin sulfate - Capsules; One capsule, three times daily.', 'armGroupLabels': ['Cosamin DS®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13330-260', 'city': 'Campinas', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Serviço de reumatologia do hospital e maternidade celso pierro da PUC-Campinas', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}], 'overallOfficials': [{'name': 'José R Provenza, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pontifícia Universidade Católica de Campinas, São Paulo, Brazil'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ache Laboratorios Farmaceuticos S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}