Trials / Terminated
TerminatedNCT04664803
Safety and Efficacy of Cefecin Tab. in Patients With Acute Sinusitis
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)
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 284 (actual)
- Sponsor
- Korea United Pharm. Inc. · Industry
- Sex
- All
- Age
- 12 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cefecin Tab. | |
| DRUG | Omnicef Cap. |
Timeline
- Start date
- 2015-08-31
- Primary completion
- 2019-06-28
- Completion
- 2019-08-31
- First posted
- 2020-12-11
- Last updated
- 2020-12-11
Source: ClinicalTrials.gov record NCT04664803. Inclusion in this directory is not an endorsement.