Safety and Efficacy of Cefecin Tab. in Patients With Acute Sinusitis
CASIS
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)
1 other identifier
interventional
284
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2015
Longer than P75 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 31, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2019
CompletedFirst Submitted
Initial submission to the registry
November 24, 2020
CompletedFirst Posted
Study publicly available on registry
December 11, 2020
CompletedDecember 11, 2020
November 1, 2020
3.8 years
November 24, 2020
December 7, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical effective rate
Percentage of patients with clinical cure and improvement on days 14 and 21
21 days
Secondary Outcomes (4)
Clinical cure rate
21 days
Clinical effective rate
14 days
Change from baseline in total score of clinical signs
14 days
Change from baseline in total score of clinical signs
21 days
Study Arms (2)
Cefecin Tab.
EXPERIMENTALCefecin Tab./Placebo to Omnicef Cap.
Omnicef Cap.
ACTIVE COMPARATOROmnicef Cap./Placebo to Cefecin Tab.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2020
First Posted
December 11, 2020
Study Start
August 31, 2015
Primary Completion
June 28, 2019
Study Completion
August 31, 2019
Last Updated
December 11, 2020
Record last verified: 2020-11