The Efficacy of Potassium-competitive Acid Blocker (P-CAB) in Patients With Laryngopharyngeal Reflux Disease: a Double- Blind, Randomized, Placebo-controlled Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Reflux symptom index (RSI)
研究概览
简要总结
Background/Aims: Tegoprazan is a novel potassium-competitive acid blocker that has a fast onset of action and can control gastric pH for a prolonged period, which could offer clinical benefit in acid-related disorders. The investigators aimed to evaluate whether tegoprazan would be more effective in controlling symptoms than placebo in patients with laryngopharyngeal reflux disease (LPRD). Methods: This double-blind, randomized, placebo-controlled trial randomly assigned 35 patients suffering LPRD symptom to two groups: Tegoprazan50mg once daily and placebo. The primary end point was complete resolution rate of LPRD symptoms after 8-week medication, and the secondary endpoints were complete resolution rate of LPRD symptoms after 4-week medication, change of reflux symptom index (RSI) and reflux finding score (RFS) from baseline at 4- and 8-week medication.
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
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least one symptom of LPRD (hoarseness, globus, persistent throat discomfort, and frequent throat clearing) for at least 4 weeks
- •Reflux symptom index > 13 and reflux finding score ≥ 7
排除标准
- •Viral or bacterial laryngopharyngitis at present
- •History of malignancy of head and neck region, esophagus and stomach
- •Previous radiotherapy or endotracheal intubation within three months
- •Previous anti-reflux surgery or gastroesophageal surgery
- •Diagnosis of depression, anxiety, panic, somatoform or other psychotic disorder
- •Taking anti-psychotics, anti-depressants or anti-anxiety drugs
- •Anti-reflux medication such as proton-pump inhibitors (within 4 weeks before screening), histamine receptor 2 blockers, antacids or prokinetics (within 2 weeks before screening)
- •Need for continuous therapy with non-steroidal anti-inflammatory drugs
- •Pregnant or breastfeeding women, as well as female patients who were not willing to use contraception for the duration of the clinical trial period
- •Abnormal laboratory test values at screening (blood urea nitrogen and serum creatine level >1.5 upper limit of normal [ULN]; total bilirubin levels and serum levels of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and gamma-glutamyl transferase > 2 ULN) or
- •Any other conditions or disease that an investigator considered not appropriate for this study
研究组 & 干预措施
placebo group
干预措施: Placebo (Drug)
tegoprazan group
干预措施: Tegoprazan (Drug)
结局指标
主要结局
Reflux symptom index (RSI)
时间窗: Week 8
RSI is a validated nine-item, self-administered questionnaire to assess the severity and responses to treatment of laryngopharyngeal reflux disease-associated symptoms. Each component is scored between 0 (no problem) and 5 (severe problem), with a maximum total score of 45. Non-response = RSI ≥ 13, Response = post-treatment RSI \< 13 and change in RSI \< 50%, Complete response = post-treatment RSI \< 13 and change in RSI ≥ 50%.
Reflux finding score (RFS)
时间窗: Week 8
RFS is a validated rating scale developed to quantify the degree of laryngeal involvement in laryngopharyngeal reflux disease during fiberoptic laryngoscopy. Scores range from 0 (no abnormal findings) to 26 (worst score possible). Normal \< 7, Abnormal ≥ 7.
次要结局
未报告次要终点