To assess the analgesic efficacy and tolerability of meloxicam 15 mg, 7.5 mg, 3.75 mg and 1.875 mg oral (rapid release tablet) compared with placebo and ibuprofen 400 mg and 200 mg administered in a single dose, over an observation period of 6 hours in the treatment of pain after surgery of the third molar.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
381
Assessment of pain intensity differences (PID) on a visual analogue scale (VAS, 100 mm) from one hour onwards
Time frame: 60, 90, 120, 180, 240, 300 and 360 minutes after drug administration
Assessment of PID on a VAS
Time frame: Up to 360 minutes after drug administration
Sum of pain intensity differences (SPID)
Time frame: Up to 360 minutes after drug administration
Number of patients with pain decrease >=50%
Time frame: Up to 360 minutes after drug administration
Assessment of maximum pain decrease on a VAS
Time frame: Up to 360 minutes after drug administration
Number of withdrawals due to safety reasons
Time frame: Up to 7 days after drug administration
Number, nature and severity of adverse events
Time frame: Up to 7 days after drug administration
Total pain relief (TOTPAR) assessed by patient (Area under the pain relief-by time curve)
Time frame: Up to 360 minutes after drug administration
Assessment of onset of analgesic action
Time frame: Up to 2 hours after surgery
Final assessment of efficacy by patient on a 4-point verbal rating scale (VRS)
Time frame: 6 hours after drug administration
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Final assessment of efficacy by investigator on a 4-point VRS
Time frame: 2 hours after drug administration
Change from baseline in laboratory values
Time frame: Baseline, up to 7 days after drug administration
Assessment of the progress of healing of the extraction site
Time frame: 3-7 days after drug administration
Patient's assessment of overall tolerability on a 4-point rating scale
Time frame: Day 7 after drug administration
Investigator's assessment of overall tolerability on a 4-point rating scale
Time frame: Day 7 after drug administration
Pain relief assessed by patient on a 5-point VRS
Time frame: Up to 360 minutesafter drug administration
Number of withdrawals due to inadequate efficacy
Time frame: Up to 7 days after drug administration