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The purpose of this study is to assess the efficacy and safety of glucosamine and chondroitin sulfate association in the treatment of patients with osteoarthrosis of the knee.
To assess the efficacy and safety of the association of glucosamine sulphate 500 mg/chondroitin sulphate 400 mg (Eurofarma) in the treatment of osteoarthritis, compared to Cosamin DS® (Nutramax) in same presentation and pharmaceutical form.
Some eligibility criteria:
Osteoarthritis of the knee confirmed by radiological examination; Visual analogue scale (VAS) > 40 mm; Clinical diagnosis of pain and functional limitation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cosamin DS® | Active Comparator | glucosamine hydrochloride 500 mg and chondroitin sulfate 400 mg (Cosamin DS®, Nutramax Laboratories). The medication was supplied as capsules, with the daily dose of 3 capsules. |
|
| Glucosamine/ chondroitin sulphate | Experimental | Glucosamine hydrochloride 500 mg and chondroitin sulphate 400 mg association (Eurofarma) T.I.D. before each meal The medication was supplied as capsules, with the daily dose of 3 capsules. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucosamine sulphate and chondroitin sulphate association | Drug | glucosamine sulphate 500 mg and chondroitin sulphate 400 mg association T.I.D. before each meal |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Assess the Efficacy and Safety of the Association of Glucosamine Sulphate 500 mg/Chondroitin Sulphate 400 mg (Eurofarma) in the Treatment of Osteoarthritis, Compared to Cosamin DS® (Nutramax)in Same Presentation and Pharmaceutical Form | To assess the efficacy and safety of the association of glucosamine sulphate 500 mg/chondroitin sulphate 400 mg (Eurofarma) in the treatment of osteoarthritis, compared to Cosamin DS® (Nutramax) in same presentation and pharmaceutical form. | approximately 5 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilberto Brandão, Phd/MD | Centro de Pesquisa Clínica Perdizes | Principal Investigator |
| Marise L. Castro, Phd/MD | Instituto de Medicina Avancada | Principal Investigator |
| Cristiano F. Zerbini, Phd/MD | Centro Paulista de Investigacoes Clínicas Ltda. | Principal Investigator |
| Jose A. Mendonça, Phd/MD | Instituo de Pesquisa Clínica e Assistencia Medica de Campinas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Pesquisa Clínica e Assistencia Medica de Campinas | Campinas | São Paulo | 13073-350 | Brazil | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30657100 | Derived | Lomonte ABV, Mendonca JA, de Castro Brandao G, Castro ML. Multicenter, randomized, double-blind clinical trial to evaluate efficacy and safety of combined glucosamine sulfate and chondroitin sulfate capsules for treating knee osteoarthritis. Adv Rheumatol. 2018 Dec 5;58(1):41. doi: 10.1186/s42358-018-0041-9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cosamin DS® | |
| FG001 | Glucosamine/Chondroitin Sulphate | Glucosamine hydrochloride 500 mg and chondroitin sulphate 400 mg association (Eurofarma) T.I.D. before each meal |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Cosamin DS® (Nutramax) | Drug | oral capsule of glucosamine hydrochloride 500 mg + chondroitin sulphate 400 mg thrice daily before meals. Period: 127 days |
|
|
| Centro Paulista de Investigacoes Clinicas Ltda |
| São Paulo |
| 04266-010 |
| Brazil |
| Centro de Pesquisa Clínica Perdizes | São Paulo | 05005-001 | Brazil |
| Instituto de Medicina Avancada | São Paulo | 05437-000 | Brazil |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cosamin DS® | |
| BG001 | Glucosamine/Chondroitin Sulphate | Glucosamine hydrochloride 500 mg and chondroitin sulphate 400 mg association (Eurofarma) T.I.D. before each meal |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | To Assess the Efficacy and Safety of the Association of Glucosamine Sulphate 500 mg/Chondroitin Sulphate 400 mg (Eurofarma) in the Treatment of Osteoarthritis, Compared to Cosamin DS® (Nutramax)in Same Presentation and Pharmaceutical Form | To assess the efficacy and safety of the association of glucosamine sulphate 500 mg/chondroitin sulphate 400 mg (Eurofarma) in the treatment of osteoarthritis, compared to Cosamin DS® (Nutramax) in same presentation and pharmaceutical form. | In this section the population analyzed was per protocol (PP). | Posted | Mean | 95% Confidence Interval | percentage of participants | approximately 5 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cosamin DS® | Glucosamine hydrochloride 500 mg and chondroitin sulphate 400 mg association (Eurofarma) T.I.D. before each meal | 3 | 50 | 5 | 50 | ||
| EG001 | Glucosamine/Chondroitin Sulphate | Glucosamine 500 mg and chondroitin sulphate 400 mg association (Eurofarma) T.I.D. before each meal | 1 | 50 | 8 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arm fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Shoulder fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Fibromyalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Heart attack | Cardiac disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | General disorders | Non-systematic Assessment |
| ||
| Hyperglycemia | Endocrine disorders | Non-systematic Assessment |
| ||
| Nausea | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Worsening Diabetes Mellitus | Endocrine disorders | Non-systematic Assessment |
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| Leg pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| dyspepsia | Endocrine disorders | Non-systematic Assessment |
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| Epigastralgia | Gastrointestinal disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eurofarma Laboratórios | Eurofarma Laboratórios | 08007043876 |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D005944 | Glucosamine |
| D002807 | Chondroitin |
| ID | Term |
|---|---|
| D006595 | Hexosamines |
| D000606 | Amino Sugars |
| D002241 | Carbohydrates |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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| >=65 years |
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| Male |
|