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

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ClinicalTrials.gov Identifier: NCT04664803
Recruitment Status : Terminated
First Posted : December 11, 2020
Last Update Posted : December 11, 2020
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Acute Sinusitis Drug: Cefecin Tab. Drug: Omnicef Cap. Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 284 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : August 31, 2015
Actual Primary Completion Date : June 28, 2019
Actual Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis
Drug Information available for: Cefdinir

Arm Intervention/treatment
Experimental: Cefecin Tab.
Cefecin Tab./Placebo to Omnicef Cap.
Drug: Cefecin Tab.
Other Name: cefetamet pivoxil

Active Comparator: Omnicef Cap.
Omnicef Cap./Placebo to Cefecin Tab.
Drug: Omnicef Cap.
Other Name: cefdinir




Primary Outcome Measures :
  1. Clinical effective rate [ Time Frame: 21 days ]
    Percentage of patients with clinical cure and improvement on days 14 and 21


Secondary Outcome Measures :
  1. Clinical cure rate [ Time Frame: 21 days ]
    Percentage of patients with clinical cure on days 14 and 21

  2. Clinical effective rate [ Time Frame: 14 days ]
    Percentage of patients with clinical cure and improvement on days 14

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Responsible Party: Korea United Pharm. Inc.
ClinicalTrials.gov Identifier: NCT04664803    
Other Study ID Numbers: KUP-CFC-401
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: December 11, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Cefdinir
Cefetamet
Anti-Bacterial Agents
Anti-Infective Agents