EUCTR2010-023239-40-SE进行中（未招募）不适用
A Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of Ciprofloxacin 0.3% plus Fluocinolone Acetonide 0.025% Otic Solution Compared to Ciprofloxacin 0.3% Otic solution and to Fluocinolone Acetonide 0.025% Otic Solution in the Treatment of Acute Otitis Media with Tympanostomy Tubes (AOMT) in Pediatric Patients.
aboratorios SALVAT, S.A.0 个研究点目标入组 330 人开始时间: 2012年4月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 330
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patient of either sex between 6 months and 12 years of age (both inclusive)
- •2. Patients with patent tympanostomy tube in the ear which will be treated (must be present and open)
- •3. Patients suffering from otorrhea for 3 weeks or less
- •4. Moderate or severe purulent otorrhea at inclusion
- •5. Signed informed consent from the patient?s legally authorized representative; also, if the patient is capable of providing assent, signed assent from the patient.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 330
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Tympanostomy tube placement 3 days or less before study entry
- •2. Tympanostomy tubes containing antiseptic or antibacterial activity (silver oxide or silver salts), T-type tubes
- •3. Acute otitis externa or malignant otitis externa
- •4. Suspected viral, fungal, or mycobacterial ear infection
- •5. Otologic surgery within the previous year (other than tympanostomy tube placement)
- •6. Mastoiditis
- •7. Known or suspected quinolone and/or corticoids hypersensitivity
- •8. History of an immunosuppressive disorder, current immunosuppressive therapy, or diabetes
- •9. Acute or chronic renal disease, active hepatitis
- •10. Chronic nasal obstruction and/or persistent rhinorrhea
- •11. Craniofacial anomalies
- •12. Patient predisposed to neurosensory hearing loss
- •13. Use of topical nonsteroidal otic agents within one day of study entry
- •14. Use of topical or otic steroids within 3 days of enrollment or systemic steroids within 7 days of enrollment
- •15. Use of intranasal or inhaled steroids within 3 days of enrollment
- •16. Any infection requiring systemic antimicrobial therapy
- •17. Use of topical or systemic antimicrobial or antifungal agents within the previous 7 days of study entry or antimicrobial therapy for the current episode of AOMT.
- •18. Concurrent use of oral anti-inflammatory agents, except ibuprofen (analgesics without anti-inflammatory properties, such as acetaminophen are allowed)
- •19. Menarcheal female
- •20. Participation in another clinical trial in the previous 30 days
研究者
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