NCT03196973已完成3 期
A Phase III, Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution Compared to DF289 Otic Solution and to DF277 Otic Solution in the Treatment of Acute Otitis Externa (AOE)
Salvat1 个研究点 分布在 1 个国家目标入组 493 人开始时间: 2017年7月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 493
- 试验地点
- 1
- 主要终点
- Therapeutic Cure (Clinical + Microbiological Cure)
研究概览
简要总结
The purpose of this study is to determine if a combination of an antibiotic plus a corticosteroid is safe and effective in treating AOE
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Uncomplicated AOE of less tan 21 days, defined as a total symptom score of at least 2 for otalgia, 2 for edema and 1 for otorrhea
- •Brighton Grading of II or III
- •Culture-based diagnosis of acute bacterial otitis externa
- •Willingness to refrain from swimming through end of the study
排除标准
- •Previous episode of AOE within 4 weeks prior to enrollment, or 2 or more episodes of AOE within 6 months prior to the enrollment.
- •Tympanic membrane perforation
- •Any condition or situation likely to cause the patient to be unable or unwilling to comply with study treatment or attend all study visits
- •Any condition in the patient or parent/guardian that, in the judgment of the principal investigator, could compromise patient safety, limit the patient's ability to complete the study, and/or compromise the objectives of the study
研究组 & 干预措施
DF289 plus DF277
Experimental
Otic solution
干预措施: DF289 plus DF277 (Drug)
DF289
Active Comparator
Otic solution
干预措施: DF289 (Drug)
DF277
Active Comparator
Otic solution
干预措施: DF277 (Drug)
结局指标
主要结局
Therapeutic Cure (Clinical + Microbiological Cure)
时间窗: End of Treatment (Day 8+2)
Therapeutic cure will be considered achieved if edema, otalgia and otorrhea are resolved with no further requirement of antimicrobial therapy and bacteriological response is Eradication or Presumed Eradication
次要结局
- Time to End of Pain(From baseline to End of Study (Day 15+2))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric PatientsAcute Otitis MediaNCT01404611Salvat331
已完成
3 期
KIDS-STEP_Betamethasone Therapy in Hospitalised Children With CAPCommunity-acquired PneumoniaNCT03474991Julia Bielicki510
已完成
2 期
Safety and Efficacy Study of BT086 to Evaluate Adjunctive Therapy in sCAPCommunity Acquired PneumoniaNCT01420744Biotest160
已完成
3 期
As Needed Beclomethasone/Salbutamol Combination in Single Inhaler for Mild Persistent AsthmaAsthmaNCT00382889Chiesi Farmaceutici S.p.A.480
已完成
3 期
A Comparison of the Effectiveness and Safety of Levofloxacin to That of Ciprofloxacin in Treating Complicated Urinary Tract Infection and Acute Pyelonephritis.Urinary Tract InfectionsPyelonephritisNCT00210886Johnson & Johnson Pharmaceutical Research & Development, L.L.C.1,109