NCT03116737已完成3 期
Phase III, Multicenter, Randomized, Double-Blind, Placebo- Controlled Parallel-Designed Evaluation to Assess Safety and Efficacy of Topical Benzocaine for Treatment of Pain Associated With Acute Otitis Media in Children Ages 5 to 12 Years
Lachlan Pharma Holdings1 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2017年1月3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
- 141
- 试验地点
- 1
- 主要终点
- Summed Pain Intensity Difference Assessed by Faces Pain Scale-Revised (FPS-R)
研究概览
简要总结
The Phase III study is designed to assess the safety, tolerability, and efficacy of Topical Benzocaine in children, ages 5 to 12 years, presenting with Acute Otitis Media-associated ear pain.
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
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients ages 5 to 12 years of age with a clinical diagnosis of unilateral AOM, and with ear pain (current episode <2 weeks duration). Baseline pain entry requires a minimum score of 4 on the FPS-R.
- •Patients/guardians must provide Institutional Review Board (IRB) approved written assent, as appropriate, which must be accompanied by an IRB approved written informed consent form (ICF) from the patient's legally acceptable representative (i.e., parent or guardian), as applicable. In addition, all patients or their legally acceptable representatives (i.e., parent or guardian) must sign a Health Insurance Portability and Accountability Act (HIPAA) authorization, if applicable.
- •Patients must be physically active and otherwise judged to be in good health on the basis of the medical history and a limited physical examination, as determined by the Investigator.
- •Females of childbearing potential must also have a negative urine human chorionic gonadotropin (hCG) pregnancy test on the Study Day, Visit 1.
排除标准
- •Patients unable or refusing to independently and consistently complete the FPS-R pain measurements.
- •Patients with bilateral AOM, perforated tympanic membrane, history of a perforated tympanic membrane in the last 6 months, or if a perforated tympanic membrane could not be ruled out by speculum examination, impedance testing tympanometry, pneumatic otoscopy, or a Valsalva maneuver.
- •Patients who are subsequently diagnosed with a perforated membrane during treatment are to be discontinued immediately.
- •Patients with indwelling tympanostomy tubes or draining otitis in the affected ear(s), bullous lesions, erythema of the tympanic membrane without other evidence of AOM, and patients with an anatomic defect of the ear or nasopharynx.
- •Complications of treated/untreated ear disease other than qualifying AOM over the past 2 weeks.
- •Patients with comorbidity requiring antibiotic therapy, allergy to study medication, immunologic deficiency, and major medical condition(s).
- •Patients presenting with methemoglobinemia or a history of methemoglobinemia, vertigo, inherited enzyme deficiencies (including G6PD), impaired cardiac or respiratory functions, epilepsy, heart diseases, hypersensitivity to benzocaine or any other related drug product, inflamed or infected skin, dermatitis, previous medication related shock episode, hepatic impairment, or myasthenia gravis.
- •Acute or chronic otitis externa.
- •Chronic otitis media (current episode ≥ 2 weeks).
- •Patients who smoke.
- •Dermatitis involving the affected external ear canal or pinna.
- •Any topical or systemic antibiotic received within the 14 days prior to study entry.
- •Patients administered vaccinations a week prior to or on any of the Study Day Visits.
- •Any ear drops, topical drying agent or over-the-counter (OTC) therapy for any ear related issue received within 36 hours prior to enrollment.
- •Fever >102°F or at any elevated level considered necessary by the study investigator.
- •Known hypersensitivity to the study drug or similar compounds including any of the inactive ingredients.
- •Patients receiving medication on a chronic basis for pain (including steroidal or non-steroidal anti-inflammatory drugs).
- •Oral analgesics such as ibuprofen/acetaminophen within 6 hours prior to study entry.
- •Use of drug products with potential interactions including sulfonamides, aminosalicylates, anti-cholinesterases, suxamethonium, antiarrhythmics, monoamine oxidase inhibitors, or tricyclic antidepressants within 14 days.
- •Eating, drinking, chewing of gum, or use of mints/lozenges during the first hour after initial study dose.
- •Children that use pacifiers and/or are still breastfed.
- •Exposure to any investigational agent within the 30 days prior to study entry.
- •Previous enrollment in this study.
- •Pregnant or lactating.
- •Clinically significant mental or emotional illnesses (by history or as determined by the on-site investigator).
- •The child has a condition or demonstrates a behavior that the Investigator or site personnel believe would interfere with the ability to provide assent (age appropriate) or comply with study instructions/tasks, or that might confound the interpretation of the study results, or put the child or others at risk.
研究组 & 干预措施
Benzocaine Otic Solution
Experimental
干预措施: Benzocaine Otic Solution (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Summed Pain Intensity Difference Assessed by Faces Pain Scale-Revised (FPS-R)
时间窗: 60 minutes
次要结局
- Use of Rescue Medications(Up to 3 days)
- Assess the Safety and Tolerability of Benzocaine Based on Physical Examinations(Up to 3 days)
- Assess the Safety and Tolerability of Benzocaine Based on Vital Signs(Up to 3 days)
- Summed Pain Intensity Difference Assessed by Faces Pain Scale-Revised (FPS-R)(120 minutes)
- Pain Intensity Difference Assessed by Faces Pain Scale-Revised (FPS-R)(Up to 3 days)
- Dosing Intervals(Up to 3 days)
- Assess the Safety and Tolerability of Benzocaine Based on Reported Adverse Events(Up to 3 days)
研究者
研究点 (1)
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