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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cefecin Tab. | Experimental | Cefecin Tab./Placebo to Omnicef Cap. |
|
| Omnicef Cap. | Active Comparator | Omnicef Cap./Placebo to Cefecin Tab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cefecin Tab. | Drug |
|
| |
| Omnicef Cap. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical effective rate | Percentage of patients with clinical cure and improvement on days 14 and 21 | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical cure rate | Percentage of patients with clinical cure on days 14 and 21 | 21 days |
| Clinical effective rate | Percentage of patients with clinical cure and improvement on days 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| C047445 | cefetamet pivoxyl |
| D000077525 | Cefdinir |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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| Drug |
|
|
| 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 | 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 | 21 days |
| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |