Osteoarthritis of the Knee
Conditions
Keywords
osteoarthritis (OA), knee
Brief summary
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.
Detailed description
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
Interventions
DRUGGlucosamine sulphate and chondroitin sulphate association
glucosamine sulphate 500 mg and chondroitin sulphate 400 mg association T.I.D. before each meal
DRUGCosamin DS® (Nutramax)
oral capsule of glucosamine hydrochloride 500 mg + chondroitin sulphate 400 mg thrice daily before meals. Period: 127 days
Sponsors
Eurofarma Laboratorios S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects have to read and sign the approved the Informed Consent form prior to any participation in the study. * Male or female Subjects, aged upper to 40 years. * Osteoarthritis of the knee confirmed by radiological examination. * Visual analogue scale (VAS) \> 40 mm. * Kellgren and Lawrence grade 1 to 3. * Clinical diagnosis of pain and functional limitation.
Exclusion criteria
* History of significant trauma or surgery in the affected joint. * Pregnant women, lactating or not using appropriate contraceptive method. * History or presence of active rheumatic disease that may be responsible for secondary osteoarthritis. * Severe inflammation of the joint confirmed by physical examination (excluding also erythrocyte sedimentation \<40mm/h and rheumatoid factor \<1:40). * Body mass index \> 30. * Hematologic abnormalities, liver, renal or metabolic functions which undermine the serious participation of the patient (at investigator's criteria). * Systemic administration and/or intra-articular corticosteroids in the last 3 months. * Have made use of glucosamine and/or chondroitin. * Lequesne index of \> 12. * Arthroplasty in the affected joint. * Use of narcotic analgesics. * Any condition that, in the opinion of the investigator, renders the patient unable to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cosamin DS® | 44 |
| Glucosamine/Chondroitin Sulphate Glucosamine hydrochloride 500 mg and chondroitin sulphate 400 mg association (Eurofarma) T.I.D. before each meal | 45 |
| Total | 89 |
Baseline characteristics
| Characteristic | Glucosamine/Chondroitin Sulphate | Cosamin DS® | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 17 Participants | 22 Participants | 39 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 22 Participants | 50 Participants |
| Age, Continuous | 63.4 years STANDARD_DEVIATION 8.3 | 64 years STANDARD_DEVIATION 10.2 | 63.7 years STANDARD_DEVIATION 9.25 |
| Region of Enrollment Brazil | 45 Participants | 44 Participants | 89 Participants |
| Sex: Female, Male Female | 43 Participants | 40 Participants | 83 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 50 | 8 / 50 |
| serious Total, serious adverse events | 3 / 50 | 1 / 50 |
Outcome results
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.
Time frame: approximately 5 months
Population: In this section the population analyzed was per protocol (PP).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cosamin DS® | 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 | 85.4 percentage of participants |
| Glucosamine/Chondroitin Sulphate | 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 | 88.9 percentage of participants |
p-value: <0.05t-test, 1 sided