Study to assess the efficacy and tolerability of Meloxicam once daily dose of 7.5 mg and 15 mg compared with 1100 mg of naproxen sodium in the symptomatic treatment of acute non bacterial pharyngitis or pharyngo-tonsillitis, over a period of 5 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
390
Change in intensity of spontaneous pharyngeal pain
Time frame: Baseline, day 3 and 5
Change in intensity of pharyngeal pain on swallowing
Time frame: Baseline, day 3 and 5
Final global assessment of efficacy by patient
Time frame: Day 5
Final global assessment of efficacy by investigator
Time frame: Day 5
Final global assessment of tolerability by patient
Time frame: Day 5
Final global assessment of tolerability by investigator
Time frame: Day 5
Occurrence of disease systemic manifestations (fever, and general malaise)
Time frame: up to 5 days
Occurrence of pharyngeal hyperemia
Time frame: up to 5 days
Assessment of patient status
Time frame: Day 5
Occurrence of treatment withdrawal due to lack of efficacy
Time frame: up to 5 days
Occurrence of perforation, ulceration, bleeding (PUB) of the upper gastro-intestinal tract (stomach or duodenum)
Time frame: up to day 5
Intensity of adverse events
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Time frame: up to 19 days
Number of patients who withdraw due to adverse event
Time frame: up to 19 days
Incidence of significant laboratory adverse events
Time frame: up to 19 days
Occurrence and duration of hospital stay due to Gastro-Intestinal Serious Adverse Events (GI-SAE)
Time frame: up to 19 days
Occurrence and duration of hospital stay due to adverse events related to trial drug administration
Time frame: up to 19 days
Occurrence of an additional visit at physician due to gastro-intestinal adverse event (GI-AE)
Time frame: up to 19 days
Number of patients with adverse events
Time frame: up to 19 days
Number of patients with adverse events related to trial drug
Time frame: up to 19 days