Double-blind Placebo Controlled Trial of the Treatment of Chronic Laryngitis With Amitriptyline
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change in Score on Reflux Symptom Index (RSI)
研究概览
简要总结
This randomized, double-blind, placebo-controlled trial will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis.
详细描述
Chronic laryngitis commonly manifests through symptoms including cough, hoarseness, throat clearing, foreign body sensation, throat pain, sensation of excessive phlegm, and difficulty swallowing. A significant minority also present with GERD, rhinosinusitis-induced post-nasal drainage, direct allergic effect, and smoking issues.
Amitriptyline is commonly used for mental/mood problems, but is also prescribed to treat chronic laryngitis because some investigators suggest a neuropathic etiology for idiopathic chronic laryngitis. No trials have compared any treatment for chronic laryngitis to placebo and it is unknown if currently used therapies for chronic laryngitis are effective.
At the baseline visit, subjects will be assigned at random to amitriptyline or placebo, which they will take for 4 weeks each. Subjects will be seen in the clinic at baseline and after 10 weeks. Improvement will be measured using standardized symptom scales, and a self-reported subjective improvement percentage.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Must be age 18 or older and able to consent for themselves
- •Must have had structural pathology such as tumor previously ruled out using flexible laryngoscopy
- •Must be able to speak and read the English language
- •Must have failed a 2 month or longer trial of a proton pump inhibitor for the treatment of gastro-esophageal reflux
- •Women under 55 years of age who may become pregnant must have a negative pregnancy test and agree to barrier or hormonal methods of contraception during the study
- •Potential subject and their physician have agreed that amitriptyline will be part of their regular care plan
排除标准
- •Active untreated environmental allergies
- •Smoking within past 5 years
- •Current upper respiratory infections
- •Use of narcotics (e.g. oxycodone, methadone) within the past week
- •Hypersensitivity to amitriptyline
- •History of amitriptyline use or of other tricyclic antidepressant - including pregabalin, gabapentin, baclofen, or other gamma-aminobutyric acid (GABA)analogues or inhibitors - for any medical condition (not limited to chronic laryngitis) within the past 12 months.
- •Use of any other monoamine oxidase inhibitors (MAOIs) other than amitriptyline within the past 4 weeks (selegiline, phenelzine, tranylcypromine, isocarboxazid, rasagiline, phenelzine sulfate, selegiline hydrochloride, rasagiline mesylate, tranylcypromine sulfate)
- •History of urinary retention
- •History of an acute episode of a major depressive disorder within the past 12 months
- •For women 18-55 years of age without history of menopause: currently nursing or pregnant, plans to become pregnant, or unwillingness to utilize contraception (barrier or hormonal methods)
- •Currently participating in another clinical trial that could interfere with the efficacy of, or participation in, this study.
- •Current untreated diagnosis of gastroesophageal reflux (GERD)
研究组 & 干预措施
amitriptyline
Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)
干预措施: Amitriptyline (Drug)
placebo
Subjects in this arm will receive pills composed only of Avicel (cellulose filler)
干预措施: Placebo (Other)
结局指标
主要结局
Change in Score on Reflux Symptom Index (RSI)
时间窗: baseline, 8 weeks
The Reflux Symptom Index (RSI) is a validated questionnaire consisting of 9 statements to be ranked on a scale of 0-5 (0=no problem, 5=severe problem). RSI scores can range from 0 to 45, with higher scores correlated with more reflux symptoms.
次要结局
- Change in the Score on the Voice Handicap Index-10 (VHI-10)(baseline, 8 weeks)
- Change in the Score on the Cough Severity Index (CSI)(baseline, 8 weeks)
- Change in Throat Pain or Burning(baseline, 8 weeks)
- Change in Pain When Swallowing(baseline, 8 weeks)
- Subjective Improvement of Laryngitis Symptoms(8 weeks)
- Number of Participants Who Dropped Out of the Study Due to Side Effects(8 weeks)