Osteoarthritis
Conditions
Brief summary
To assess the efficacy and safety of meloxicam 7.5mg once daily compared with diclofenac 100mg SR once daily over a treatment period of 8 weeks
Interventions
DRUGDiclofenac
DRUGMeloxicam
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Osteoarthritis of the knee requiring the therapy with non-steroidal anti-inflammatory drugs (NSAIDs)
Exclusion criteria
\- none
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in pain on active movement assessed by a 100 mm visual analogue Scale (VAS) | Baseline, 8 weeks after first drug administration |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Lequesne index | Baseline, 8 weeks after first drug administration |
| Change from baseline in global assessment by the patient and doctor on a 3-point scale | Baseline, 8 weeks after first drug administration |
| Number of patients with significant changes from baseline in Laboratory values | Baseline, 8 weeks after first drug administration |
| Number of patients with significant changes from baseline in physical examinations | Baseline, 8 weeks after first drug administration |
| Number of patients with Adverse Events | Up to 8 weeks after first drug administration |
Outcome results
None listed