Osteoarthritis
Conditions
Keywords
pain, Knee
Brief summary
Phase III Study, double-blind, comparing association of anti-inflammatory and anti-rheumatic in 375 subjects with knee osteoarthritis.
Detailed description
Evaluation after 12 weeks of treatment, in 3 arms, the efficacy and safety of the association.
Interventions
DRUGMeloxicam and Glucosamine
Experimental
DRUGMeloxicam
Active Comparator
DRUGGlucosamine
Active Comparator
Sponsors
Eurotrials Brasil Consultores Cientificos Ltda
Zodiac Produtos Farmaceuticos 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 85 Years
Healthy volunteers
No
Inclusion criteria
* Signs the Informed Consent Form * Age between 40 and 85 years * osteoarthritis of the knee according to clinical and radiological criteria of the American College of Rheumatology
Exclusion criteria
* Cardiovascular disease * Serious chronic comorbidity * Hypersensitivity to any component of the study drugs * body mass index\> 30 kg / m²
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy measured by decrease in score algofunctional Lequesne index after 12 weeks from the start of treatment | 12 weeks | Decrease in score of algofunctional Lequesne index after 12 weeks from the start of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety measured by frequency of adverse event | 12 weeks | Safety as measured by total frequency of adverse event during the 12 weeks of treatment |
Contacts
Primary ContactCarine F Sanches, Pharmacist
Backup ContactValery F Carvalho, Biologist
Outcome results
None listed