NCT02123498撤回4 期
The Study of the Diagnosis of Eustachian Tube Dysfunction (ETD): Identifying the Relationship of Ear Fullness to Laryngopharyngeal Reflux (LPR)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Evidence of laryngopharyngeal reflux in patients complaining of ear fullness/pressure/pain
研究概览
简要总结
The purpose of this study is to investigate the relationship between ear fullness, pressure, and/or pain and laryngopharyngeal reflux, in order to focus medical therapy and improve therapeutic outcomes in this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •They complain of symptoms of ear fullness, ear pain, and/or ear pressure, either unilateral or bilateral
- •They are willing to participate in the study.
- •They are between the ages of 18 to 80
排除标准
- •They have had major ear surgery (not including tympanostomy tubes)
- •They have a medical condition that is another possible etiology of ear pain or acid reflux and may require additional medical or surgical intervention such as: Acute or chronic otitis externa, Chronic otitis media, Temporomandibular joint dysfunction, Upper aerodigestive track neoplasm, History of head/neck radiation therapy.
- •They are pregnant. Proton pump inhibitors are a Category C drug with unknown pregnancy risks.
- •They do not wish to participate in the study
- •They are <18 or >80.
研究组 & 干预措施
Single Arm
Experimental
干预措施: Omeprazole (Drug)
Single Arm
Experimental
干预措施: Ranitidine (Drug)
Single Arm
Experimental
干预措施: Pantoprazole (Drug)
Single Arm
Experimental
干预措施: 24-Hour Diagnostic pH-Probe Test (Procedure)
Single Arm
Experimental
干预措施: Laryngoscopy (Procedure)
结局指标
主要结局
Evidence of laryngopharyngeal reflux in patients complaining of ear fullness/pressure/pain
时间窗: 1 year
Participants complaining of ear pain, ear fullness, or ear pain are diagnosed with laryngopharyngeal reflux via laryngoscope exam and measurement by diagnostic pH-probe test.
次要结局
未报告次要终点
研究者
研究点 (2)
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