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

K

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

284 participants in 2 patient groups

Cefecin Tab.
Experimental group
Description:
Cefecin Tab./Placebo to Omnicef Cap.
Treatment:
Drug: Cefecin Tab.
Omnicef Cap.
Active Comparator group
Description:
Omnicef Cap./Placebo to Cefecin Tab.
Treatment:
Drug: Omnicef Cap.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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