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

Korea United Pharm

Status and phase

Terminated

Phase 4

Conditions

Acute Sinusitis

Treatments

Drug: Omnicef Cap.

Drug: Cefecin Tab.

Study type

Interventional

Funder types

Industry

Identifiers

NCT04664803

KUP-CFC-401

Details and patient eligibility

About

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

Full description

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.

Enrollment

284 patients

Sex

All

Ages

12 to 75 years old

Volunteers

No Healthy Volunteers

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