NCT00517114已完成不适用
Prospective Double-blinded Randomized Controlled Trial of 12-weeks High Dose Rabeprazole (Pariet) in the Treatment of Reflux Laryngitis in Chinese Patients
Hospital Authority, Hong Kong1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2005年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Symptoms assessment, quality of life.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of rabeprazole (pariet) versus placebo in treating reflux laryngitis in Chinese patients. Patients who attend the voice clinic of Department of ENT, Queen Mary hospital with suspected reflux laryngitis will be recruited. A questionnaire will be administered by the research assistant of the Department of Medicine and ENT, Queen Mary hospital. A 12-week course of PPI versus placebo trial will be commenced and patients' symptoms and signs will be documented at 6-week and 12-week time. The study will finish after a 12-week course of rabeprazole.
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
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
- •Ambulatory patients with age between 18-80 years old
- •Patients with newly presented laryngitis.
排除标准
- •They were under 18 or over 80 years of age
- •Has significant concomitant medical disease
- •Pregnancy or lactating women
- •Chronic cough attributable to known chronic pulmonary or tracheobronchial disease
- •Previous glottal surgery, radiotherapy or malignancy
- •Acid suppressive therapy within 4 wk prior to recruitment
- •Pharyngo-laryngeal infection in the previous 3 months
- •Tracheal intubation in previous 12 months
- •Immunosuppression and use of inhaled corticosteroid
结局指标
主要结局
Symptoms assessment, quality of life.
时间窗: 12 weeks
次要结局
- Compliance(4 weeks)
- Adverse effects(4 weeks)
研究者
研究点 (1)
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