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| Name | Class |
|---|---|
| Eurotrials Brasil Consultores Cientificos Ltda | INDUSTRY |
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Phase III Study, double-blind, comparing association of anti-inflammatory and anti-rheumatic in 375 subjects with knee osteoarthritis.
Evaluation after 12 weeks of treatment, in 3 arms, the efficacy and safety of the association.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kit 1 ( ML + CG ) + P | Experimental | One sachet meloxicam and glucosamine and 1 placebo tablet once a day for 12 weeks One sachet |
|
| Kit 2 ( ML + P) | Active Comparator | One tablet of meloxicam and one sachet of placebo once per day for 12 weeks |
|
| Kit 3 ( P+ GC) | Active Comparator | One sachet of glucosamine and one tablet placebo once a day for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meloxicam and Glucosamine | Drug | Experimental |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy measured by decrease in score algofunctional Lequesne index after 12 weeks from the start of treatment | Decrease in score of algofunctional Lequesne index after 12 weeks from the start of treatment | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety measured by frequency of adverse event | Safety as measured by total frequency of adverse event during the 12 weeks of treatment | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carine F Sanches, Pharmacist | Contact | 55 11 55015332 | carine.sanches@zodiac.com.br | |
| Valery F Carvalho, Biologist | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Edio Costa, Doctor | CRM | Study Chair |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000077239 | Meloxicam |
| D005944 | Glucosamine |
| ID | Term |
|---|---|
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D013844 | Thiazoles |
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| Meloxicam | Drug | Active Comparator |
|
|
| Glucosamine | Drug | Active Comparator |
|
|
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006595 | Hexosamines |
| D000606 | Amino Sugars |
| D002241 | Carbohydrates |