Osteoarthritis
Conditions
Brief summary
To Access the Efficacy and Safety of Meloxicam 7.5mg once daily over a treatment period of 56 days
Interventions
DRUGMeloxicam
Sponsors
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
34 Years to 74 Years
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 (100 mm, VAS) | Baseline, 8 weeks after first drug administration |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in physical examination (tenderness) | Baseline, 8 weeks after first drug administration |
| Assessment of significant change from baseline in status according endoscopy | Baseline, 8 weeks after first drug administration |
| Assessment of significant change from baseline in gastrointestinal (GI) symptoms score | Baseline, 8 weeks after first drug administration |
| Change from baseline in Lequesne index | Baseline, 8 weeks after first drug administration |
| Number of Patients with Adverse Events | Up to 8 weeks after first drug administration |
| Assessment of significant change from baseline in physical examination (swelling) | Baseline, 8 weeks after treatment |
| Assessment of significant change from baseline in laboratory values | Baseline, 8 weeks after first drug administration |
Outcome results
None listed