NCT04664803
Terminated
Phase 4
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)
Overview
- Phase
- Phase 4
- Intervention
- Cefecin Tab.
- Conditions
- Acute Sinusitis
- Sponsor
- Korea United Pharm. Inc.
- Enrollment
- 284
- Primary Endpoint
- Clinical effective rate
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
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
Detailed 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Cefecin Tab.
Cefecin Tab./Placebo to Omnicef Cap.
Intervention: Cefecin Tab.
Omnicef Cap.
Omnicef Cap./Placebo to Cefecin Tab.
Intervention: Omnicef Cap.
Outcomes
Primary Outcomes
Clinical effective rate
Time Frame: 21 days
Percentage of patients with clinical cure and improvement on days 14 and 21
Secondary Outcomes
- Clinical cure rate(21 days)
- Clinical effective rate(14 days)
- Change from baseline in total score of clinical signs(21 days)
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