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

December 7, 2020 updated by: Korea United Pharm. Inc.

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)

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

284

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 75 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cefecin Tab.
Cefecin Tab./Placebo to Omnicef Cap.
Drug: Cefecin Tab.
Other Names:
  • cefetamet pivoxil
ACTIVE_COMPARATOR: Omnicef Cap.
Omnicef Cap./Placebo to Cefecin Tab.
Drug: Omnicef Cap.
Other Names:
  • cefdinir

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea United Pharm. Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 31, 2015

Primary Completion (ACTUAL)

June 28, 2019

Study Completion (ACTUAL)

August 31, 2019

Study Registration Dates

First Submitted

November 24, 2020

First Submitted That Met QC Criteria

December 7, 2020

First Posted (ACTUAL)

December 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 11, 2020

Last Update Submitted That Met QC Criteria

December 7, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUP-CFC-401

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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