A Study to Access the Efficacy and Safety of Meloxicam in Patients With Osteoarthritis of the Knee
- Registration Number
- NCT02183116
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To Access the Efficacy and Safety of Meloxicam 7.5mg once daily over a treatment period of 56 days
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Osteoarthritis of the knee requiring the therapy with non-steroidal anti-inflammatory drugs (NSAIDs)
Exclusion Criteria
none
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Meloxicam Meloxicam -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change from baseline in Lequesne index Baseline, 8 weeks after first drug administration 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 Assessment of significant change from baseline in laboratory values 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