MedDataX Logo

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

NCT ID: NCT04664803

Last Updated: 2020-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

284 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2019-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Sinusitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cefecin Tab.

Cefecin Tab./Placebo to Omnicef Cap.

Group Type EXPERIMENTAL

Cefecin Tab.

Intervention Type DRUG

Omnicef Cap.

Omnicef Cap./Placebo to Cefecin Tab.

Group Type ACTIVE_COMPARATOR

Omnicef Cap.

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cefecin Tab.

Intervention Type DRUG

Omnicef Cap.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

cefetamet pivoxil cefdinir

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Korea United Pharm. Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KUP-CFC-401

Identifier Type: -

Identifier Source: org_study_id