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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Acute Sinusitis

Intervention / Treatment
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* Drug: Cefecin Tab.
* Drug: Omnicef Cap.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cefecin Tab.<br>Cefecin Tab./Placebo to Omnicef Cap. | Drug: Cefecin Tab.<br> <br> * Other names: cefetamet pivoxil;|
| Active Comparator: Omnicef Cap.<br>Omnicef Cap./Placebo to Cefecin Tab. | Drug: Omnicef Cap.<br> <br> * Other names: cefdinir;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical effective rate | Percentage of patients with clinical cure and improvement on days 14 and 21 | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure rate | Percentage of patients with clinical cure on days 14 and 21 | 21 days | 
| Clinical effective rate | Percentage of patients with clinical cure and improvement on days 14 | 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 | 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 | 21 days |