Acute SinusitisPhase 4CASISNCT04664803
Safety and Efficacy of Cefecin Tab. in Patients With Acute Sinusitis
A Phase 4 study testing Cefecin Tab. and Omnicef Cap. in people with Acute Sinusitis, run by Korea United Pharm. Inc..
Trial 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 Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Acute Sinusitis
- What is being tested?
- Cefecin Tab. and Omnicef Cap.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2015to 31 Aug 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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)
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
Read the 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.
- Conditions
- Acute Sinusitis
- Being tested
- Cefecin Tab., Omnicef Cap.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefecin Tab.Drug
Also called cefetamet pivoxil
Omnicef Cap.Drug
Also called cefdinir
| Study group | Role | What they receive |
|---|---|---|
| Cefecin Tab. | Experimental | Cefecin Tab./Placebo to Omnicef Cap. Receives: Drug: Cefecin Tab. |
| Omnicef Cap. | Active comparator | Omnicef Cap./Placebo to Cefecin Tab. Receives: Drug: Omnicef Cap. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical effective rate
Percentage of patients with clinical cure and improvement on days 14 and 21
Measured: 21 days
Secondary outcomes (4)
Clinical cure rate
Percentage of patients with clinical cure on days 14 and 21
Measured: 21 days
Clinical effective rate
Percentage of patients with clinical cure and improvement on days 14
Measured: 14 days
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
Measured: 14 days
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
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start31 Aug 2015
- Primary completion28 Jun 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea United Pharm. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664803
- Sponsor's protocol ID
- KUP-CFC-401
- Acronym
- CASIS
- Status last verified
- Nov 2020
- First submitted
- 24 Nov 2020
- Last updated
- 11 Dec 2020
- Results posted
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04664803
- Acronym / sponsor ID
- CASIS / KUP-CFC-401
- Conditions
- Acute Sinusitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Korea United Pharm. Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2015 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cefecin Tab. | Experimental | Drug: Cefecin Tab.Cefecin Tab./Placebo to Omnicef Cap. |
| Omnicef Cap. | Active comparator | Drug: Omnicef Cap.Omnicef Cap./Placebo to Cefecin Tab. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cefecin Tab.Also: cefetamet pivoxil | Drug | Cefecin Tab. |
| Omnicef Cap.Also: cefdinir | Drug | Omnicef Cap. |
Primary outcome
Clinical effective rate
Time frame: 21 days
Percentage of patients with clinical cure and improvement on days 14 and 21
4 secondary outcomes
Clinical cure rate
Time frame: 21 days
Clinical effective rate
Time frame: 14 days
Change from baseline in total score of clinical signs
Time frame: 14 days
Change from baseline in total score of clinical signs
Time frame: 21 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cefecin Tab. and Omnicef Cap. in people with Acute Sinusitis, run by Korea United Pharm. Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical effective rate (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020.