This is a multi-center, double-blind, randomized, active controlled, parallel group phase 4 clinical trial to re-confirm the efficacy and safety of cefetamet pivoxil formulation in sinusitis patients
Patients with acute sinusitis were randomly assigned (1:1) to receive either cefetamet (500 mg twice daily, study group) or cefdinir (100 mg three times a day, control group) and corresponding placebo t.i.d. or b.i.d. for 2 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
284
Clinical effective rate
Percentage of patients with clinical cure and improvement on days 14 and 21
Time frame: 21 days
Clinical cure rate
Percentage of patients with clinical cure on days 14 and 21
Time frame: 21 days
Clinical effective rate
Percentage of patients with clinical cure and improvement on days 14
Time frame: 14 days
Change from baseline in total score of clinical signs
Evaluation of clinical signs through nasal endoscopy; purulent secretion from sinus ostia, pain over sinuses, facial swelling
Time frame: 14 days
Change from baseline in total score of clinical signs
Evaluation of clinical signs through nasal endoscopy; purulent secretion from sinus ostia, pain over sinuses, facial swelling
Time frame: 21 days
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