NCT00637416终止4 期
The Effect of Dietary Control Alone Versus Dietary Control Plus Use of Proton Pump Inhibitors to Treat Pediatric Hoarseness
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change in Condition Over Treatment Period
研究概览
简要总结
This study will examine whether lansoprazole (Prevacid) and dietary control versus dietary control alone will improve pediatric hoarseness symptoms.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy children with a diagnosis of dysphonia age 3-18 years.
- •Dysphonia must be present for at least one month duration.
- •May have vocal cord nodules present.
- •Pre-enrollment flexible fiberoptic laryngoscopy must not show any potentially life-threatening cause, including but not limited to laryngeal papillomatosis, congenital glottic webs, vocal cord paralysis, or benign and malignant neoplasms.
- •Must be able to cooperate with recording of voice for analysis(3 seconds of sustained vowel).
- •Caregiver must be able to read, write, and understand English.
- •Patient with history of diagnosed asthma must have their asthma well controlled and treated at the time of enrollment for study.
排除标准
- •Dysphonia must not be due to a potentially life-threatening cause, such as laryngeal papillomatosis, congenital glottic webs, vocal cord paralysis, or benign and malignant neoplasms. This will be determined by visualization with flexible fiberoptic laryngoscopy.
- •Dysphonia must not be due to an acute upper respiratory infection.
- •Must not have been treated with proton pump inhibitor medication in the past 12 months.
- •Inability of child to cooperate with recording of voice for analysis.
- •Inability of caregiver to read, write, and understand English.
- •Mental retardation, cognitive impairment, or developmental delay.
- •History of allergic reaction of any kind to lansoprazole or any other proton pump inhibitor.
研究组 & 干预措施
Lansoprazole and dietary control
Active Comparator
Lansoprazole and dietary control
干预措施: Lansoprazole (Drug)
Placebo and dietary control
Placebo Comparator
Dietary control and placebo
干预措施: Placebo (Other)
结局指标
主要结局
Change in Condition Over Treatment Period
时间窗: 3 months
Change measured using voice assessment protocol-Grade, Roughness, Breathiness, Asthenia, Strain (GRBAS).
次要结局
未报告次要终点
研究者
研究点 (1)
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