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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
192
Overall pain during the previous 48 hours assessed on a Visual Analogue Scale (VAS)
Time frame: 6 weeks
Functional Index of ankylosing spondylitis of Dougados
Time frame: 6 weeks
Overall assessment of disease activity by the patient on VAS
Time frame: 6 weeks
Overall assessment of disease activity by the investigator on a VAS
Time frame: 6 weeks
Global efficacy assessed by the patient (verbal rating scale)
Time frame: 6 weeks
Global efficacy assessed by the investigator (verbal rating scale)
Time frame: 6 weeks
Duration of morning stiffness
Time frame: 6 weeks
Evaluation of spinal pain by the investigator (verbal rating scale)
Time frame: 6 weeks
Assessment of Schober test
Time frame: 6 weeks
Assessment of Chest expansion
Time frame: 6 weeks
Assessment of Fingers - to - floor test
Time frame: 6 weeks
Assessment of Night pain (verbal rating scale)
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Time frame: 6 weeks
Total number of study withdrawals
Time frame: 6 weeks
Number of study withdrawals due to lack of efficacy
Time frame: 6 weeks
Assessment of Paracetamol consumption
Time frame: 6 weeks
Assessment of Patient status with regard to disease condition
Time frame: 6 weeks