Study of Association of Anti-inflammatory and Anti-rheumatic
Phase 3
- Conditions
- Osteoarthritis
- Interventions
- Registration Number
- NCT02448199
- Lead Sponsor
- Zodiac Produtos Farmaceuticos S.A.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 375
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Kit 1 ( ML + CG ) + P Meloxicam and Glucosamine One sachet meloxicam and glucosamine and 1 placebo tablet once a day for 12 weeks One sachet Kit 2 ( ML + P) Meloxicam One tablet of meloxicam and one sachet of placebo once per day for 12 weeks Kit 3 ( P+ GC) Glucosamine One sachet of glucosamine and one tablet placebo once a day for 12 weeks
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Safety measured by frequency of adverse event 12 weeks Safety as measured by total frequency of adverse event during the 12 weeks of treatment