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

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)

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04664803

Acronym

CASIS

Enrollment

284

Registered

2020-12-11

Start date

2015-08-31

Completion date

2019-08-31

Last updated

2020-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Sinusitis

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.

Interventions

DRUGCefecin Tab.

DRUGOmnicef Cap.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Clinical effective rate	21 days	Percentage of patients with clinical cure and improvement on days 14 and 21

Secondary

Measure	Time frame	Description
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	14 days	Evaluation of clinical signs through nasal endoscopy; purulent secretion from sinus ostia, pain over sinuses, facial swelling

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026