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This is an open, prospective, randomized, controlled, parallel, multicenter, non-inferiority study in 250 individuals (125 individuals per group), with 204 evaluable patients with clinical and radiological diagnosis of osteoarthritis of the knee.
Individuals will be randomized to receive during 180 days the test drug(glucosamine sulfate 500 mg + sodium chondroitin sulfate 400 mg - Mantecorp) or the reference medication (glucosamine sulfate 500 mg + sodium chondroitin sulfate 400 mg - Condroflex®).
Efficacy will be evaluated through the clinical picture, pain visual analog scale, swelling, stiffness in the joint, consumption of paracetamol and quality of life.
The safety assessment will be done by monitoring the incidence of adverse events and their relation to the treatment.
This is an open, prospective, randomized, controlled, parallel, multicenter, non-inferiority study in 250 individuals (125 individuals per group), with 204 evaluable patients with clinical and radiological diagnosis of osteoarthritis of the knee.
The subjects in this study are immunocompetent men and women, aged between 55 and 80 years, diagnosed with osteoarthritis of the knee.
The inclusion will be competitive.
Individuals who qualify in the screening period will be randomized to receive during 180 days one of the following regimens below:
Efficacy will be evaluated through the clinical picture, pain visual analog scale, swelling, stiffness in the joint, consumption of paracetamol and quality of life.
The safety assessment will be done by monitoring the incidence of adverse events and their relation to the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucosamine-Chondroitin Mantecorp | Experimental | 1 capsule three times daily before meals (drug test - glucosamine sulfate 500 mg + sodium chondroitin sulfate 400 mg - Mantecorp) |
|
| Condroflex | Active Comparator | 1 capsule three times daily before meals (reference medication - glucosamine sulfate 500 mg + sodium chondroitin sulfate 400 mg - Condroflex ®). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucosamine sulfate + chondroitin sulfate - MANTECORP | Drug | 1 capsule three times daily before meals (glucosamine sulfate 500 mg + sodium chondroitin sulfate 400 mg). |
|
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC Index | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip. | 180 days |
| Paracetamol use | Another primary outcome measure is the frequency of use of analgesic medication (paracetamol). | 180 days |
| Adverse events | Adverse events related to the reference and the test drug will be recorded and used as another primary outcome measure. | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective assessment of response to therapy by the investigator and patient | Subjective criteria for evaluating effectiveness: Edema - will be evaluated according to the opinion of the physician using the Visual Analogue Scale (VAS). Pain - will be assessed according to the opinion of the patient using a visual analog scale (VAS). Stiffness in the joint - will be evaluated via the diary and through the patient's opinion also using the Visual Analogue Scale (VAS) |
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Inclusion Criteria:
Grade 1: doubtful narrowing of joint space and possible osteophyte edge Grade 2: defined osteophytes, moderate joint space narrowing Grade 3: moderate multiple osteophytes, definite reduction in joint space, some sclerosis and possible deformity of bone contour Grade 4: large osteophytes, marked joint space narrowing, severe sclerosis and definite deformity of bone contour
Exclusion Criteria:
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| Glucosamine sulfate + chondroitin sulfate - CONDROFLEX | Drug | 1 capsule three times daily before meals (glucosamine sulfate 500 mg + sodium chondroitin sulfate 400 mg). |
|
|
| 180 days |
| Subjective evaluation of tolerability graded as excellent, good, regular or poor | Subjective evaluation of tolerability to the test and reference drugs will be used as secondary outcome measures. Tolerability will be classified as:
| 180 days |
| 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 |
| ID | Term |
|---|---|
| D006595 | Hexosamines |
| D000606 | Amino Sugars |
| D002241 | Carbohydrates |
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