Spondylitis, Ankylosing
Conditions
Brief summary
Study to assess the efficacy and safety of meloxicam suppository 15 mg once daily, meloxicam tablet 15 mg once daily compared with Indomethacin suppository (50 mg daily) in patients with ankylosing spondylitis
Interventions
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
* Active ankylosing spondylitis (pain rated \>= 40 mm on a VAS and increased of at least 30% after nonsteroidal anti-inflammatory drugs (NSAIDs) wash-out)), without peripheral arthritis and inflammatory bowel disease
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall pain during the previous 48 hours assessed on a Visual Analogue Scale (VAS) | 6 weeks |
| Functional Index of ankylosing spondylitis of Dougados | 6 weeks |
| Overall assessment of disease activity by the patient on VAS | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Duration of morning stiffness | 6 weeks |
| Evaluation of spinal pain by the investigator (verbal rating scale) | 6 weeks |
| Assessment of Schober test | 6 weeks |
| Assessment of Chest expansion | 6 weeks |
| Assessment of Fingers - to - floor test | 6 weeks |
| Overall assessment of disease activity by the investigator on a VAS | 6 weeks |
| Total number of study withdrawals | 6 weeks |
| Number of study withdrawals due to lack of efficacy | 6 weeks |
| Assessment of Paracetamol consumption | 6 weeks |
| Assessment of Patient status with regard to disease condition | 6 weeks |
| Assessment of Night pain (verbal rating scale) | 6 weeks |
| Global efficacy assessed by the patient (verbal rating scale) | 6 weeks |
| Global efficacy assessed by the investigator (verbal rating scale) | 6 weeks |
Outcome results
None listed