NCT00628667已完成4 期
A Multicenter, Double -Blind, Placebo-controlled Study to Evaluate the Effects of Esomeprazole 40mg Bid on the Signs and Symptoms of Chronic Posterior Laryngitis With Suspected Laryngopharyngeal Reflux
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 120
- 主要终点
- Daily diary cards and investigator symptom assessment to evaluate the efficacy of acid suppression therapy on symptoms associated with chronic posterior laryngitis (CPL) in patients without documented pharyngeal acid
研究概览
简要总结
This study looks at how effective acid suppression therapy is on symptoms associated with chronic posterior laryngitis (CPL) in patients with documented pharyngeal acid reflux.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •One or more of the following symptoms present for at least 3 consecutive months: throat clearing, cough, globus, sore throat, or hoarseness.
- •Patients must complete a run-in diary card, and this will be looked at to ensure met the inclusion criteria.
- •Must have a total score of 5 or more on the Chronic Posterior Laryngitis Index (CPLI) grading system.
排除标准
- •A number of diseases / conditions would preclude a patient from taking part in the study, as listed in the protocol.
- •If the patient is on certain medications this will also preclude them from taking part.
研究组 & 干预措施
1
Experimental
干预措施: Esomeprazole (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Daily diary cards and investigator symptom assessment to evaluate the efficacy of acid suppression therapy on symptoms associated with chronic posterior laryngitis (CPL) in patients without documented pharyngeal acid
时间窗: Dialy diary cards, investigator assessments, laryngoscopy at week 16
次要结局
- Daily diary cards and investigator symptom assessment throughout to evaluate the efficacy of acid suppression therapy on resolution of signs of CPL at weeks 8 and 16 in patients without documented pharyngeal acid reflux.(Dialy diary cards, investigator assessments, laryngoscopy at weeks 8 and 16)
- Quality of life Questionnaire(Quality of life questionnaire completed at screening and week 16)
- To evaluate the safety and tolerability by collecting an ongoing record of adverse events.(Ongoing to week 16.)
研究者
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