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

Acute Sinusitis Clinical Trial

— CASIS  

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04664803
• Other study ID #: KUP-CFC-401
• Status: Terminated
• Phase: Phase 4
• Start date: August 31, 2015
• Est. completion date: August 31, 2019

Study information

• Verified date: November 2020
• Source: Korea United Pharm. Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 284
• Est. completion date: August 31, 2019
• Est. primary completion date: June 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Sinusitis
• Sinusitis

Intervention

Drug:
• Cefecin Tab.

• Omnicef Cap.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Korea United Pharm. Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical effective rate	Percentage of patients with clinical cure and improvement on days 14 and 21	21 days
Secondary	Clinical cure rate	Percentage of patients with clinical cure on days 14 and 21	21 days
Secondary	Clinical effective rate	Percentage of patients with clinical cure and improvement on days 14	14 days
Secondary	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
Secondary	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