Safety and Efficacy of Cefecin Tab. in Patients With Acute Sinusitis

A Clinical Trial to Re-confirm the Efficacy and the Safety of Cefetamet Pivoxil Formulation in Sinusitis Patients: Double Blinded, Randomized, Parallel Designed, Multi-center, Active Comparator Study (CASIS Study)

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.

Inclusion Criteria:

• Patients diagnosed with sinusitis (accompanied with otitis media) at screening, and whose first symptoms occurred within the past 3 weeks
• Symptoms or signs of acute sinusitis persist without improvement for 10 days after onset or symptoms or signs of acute sinusitis initially improve and then worsen within 10 days

Exclusion Criteria:

• Those who have a history of hypersensitivity to cephalosporin, penicillin, or other beta-lactam antibiotics
• Those with a history of allergic rhinitis or other rhinitis
• Those who have been diagnosed with sinusitis more than 3 times within a year
• Have had or scheduled sinus surgery within 1 month
• Creatinine Clearance < 40 mL/min at screening
• Those whose AST, ALT, and total bilirubin are more than 3 times the upper limit of normal at screening
• Cystic fibrosis patients