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

Phase 4

Terminated

• Conditions: Acute Sinusitis
• Interventions: Drug: Cefecin Tab.; Drug: Omnicef Cap.

• Registration Number: NCT04664803
• Lead Sponsor: Korea United Pharm. Inc.

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.

Study Timeline

• Study Start: 2015-08-31
• Primary Completion: 2019-06-28
• Study Completion: 2019-08-31
• Status Verified: 2020-11
• Study First Submitted: 2020-11-24
• Study First Submitted QC: 2020-12-07
• Last Update Submitted: 2020-12-07
• Study First Posted: 2020-12-11
• Last Update Posted: 2020-12-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 284

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cefecin Tab.	Cefecin Tab.	Cefecin Tab./Placebo to Omnicef Cap.
Omnicef Cap.	Omnicef Cap.	Omnicef Cap./Placebo to Cefecin Tab.

Primary Outcome Measures

Name	Time	Method
Clinical effective rate	21 days	Percentage of patients with clinical cure and improvement on days 14 and 21

Secondary Outcome Measures

Name	Time	Method
Clinical cure rate	21 days	Percentage of patients with clinical cure on days 14 and 21
Clinical effective rate	14 days	Percentage of patients with clinical cure and improvement on days 14
Change from baseline in total score of clinical signs	21 days	Evaluation of clinical signs through nasal endoscopy; purulent secretion from sinus ostia, pain over sinuses, facial swelling