NCT04664803终止4 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 284
- 主要终点
- Clinical effective rate
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cefecin Tab.
Experimental
Cefecin Tab./Placebo to Omnicef Cap.
干预措施: Cefecin Tab. (Drug)
Omnicef Cap.
Active Comparator
Omnicef Cap./Placebo to Cefecin Tab.
干预措施: Omnicef Cap. (Drug)
结局指标
主要结局
Clinical effective rate
时间窗: 21 days
Percentage of patients with clinical cure and improvement on days 14 and 21
次要结局
- Clinical cure rate(21 days)
- Clinical effective rate(14 days)
- Change from baseline in total score of clinical signs(21 days)
研究者
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