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

Primary Purpose

Acute Sinusitis

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Cefecin Tab.
Omnicef Cap.
Sponsored by
Korea United Pharm. Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Sinusitis

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Cefecin Tab.

    Omnicef Cap.

    Arm Description

    Cefecin Tab./Placebo to Omnicef Cap.

    Omnicef Cap./Placebo to Cefecin Tab.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    November 24, 2020
    Last Updated
    December 7, 2020
    Sponsor
    Korea United Pharm. Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04664803
    Brief Title
    Safety and Efficacy of Cefecin Tab. in Patients With Acute Sinusitis
    Acronym
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Terminated
    Study Start Date
    August 31, 2015 (Actual)
    Primary Completion Date
    June 28, 2019 (Actual)
    Study Completion Date
    August 31, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Korea United Pharm. Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Sinusitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    284 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cefecin Tab.
    Arm Type
    Experimental
    Arm Description
    Cefecin Tab./Placebo to Omnicef Cap.
    Arm Title
    Omnicef Cap.
    Arm Type
    Active Comparator
    Arm Description
    Omnicef Cap./Placebo to Cefecin Tab.
    Intervention Type
    Drug
    Intervention Name(s)
    Cefecin Tab.
    Other Intervention Name(s)
    cefetamet pivoxil
    Intervention Type
    Drug
    Intervention Name(s)
    Omnicef Cap.
    Other Intervention Name(s)
    cefdinir
    Primary Outcome Measure Information:
    Title
    Clinical effective rate
    Description
    Percentage of patients with clinical cure and improvement on days 14 and 21
    Time Frame
    21 days
    Secondary Outcome Measure Information:
    Title
    Clinical cure rate
    Description
    Percentage of patients with clinical cure on days 14 and 21
    Time Frame
    21 days
    Title
    Clinical effective rate
    Description
    Percentage of patients with clinical cure and improvement on days 14
    Time Frame
    14 days
    Title
    Change from baseline in total score of clinical signs
    Description
    Evaluation of clinical signs through nasal endoscopy; purulent secretion from sinus ostia, pain over sinuses, facial swelling
    Time Frame
    14 days
    Title
    Change from baseline in total score of clinical signs
    Description
    Evaluation of clinical signs through nasal endoscopy; purulent secretion from sinus ostia, pain over sinuses, facial swelling
    Time Frame
    21 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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