Double-blind Placebo Controlled Trial of the Treatment of Chronic Laryngitis With Amitryptiline
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reflux Symptom Index
研究概览
简要总结
The study will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis.
详细描述
The study will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis. At the baseline visit, subjects will be assigned at random to amitriptyline or placebo which they will take for 8 weeks. Subjects will be seen in the clinic at baseline and at 8 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older and able to consent for themselves.
- •Structural pathology such as tumor previously ruled out using flexible laryngoscopy.
- •Able to speak and read the English language.
- •Failed a trial of a proton pump inhibitor for the treatment of gastopharyngeal 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.
排除标准
- •Environmental allergies.
- •Smoking within past 5 years.
- •Using ginko bilboa (or unwilling to cease using it).
- •Current upper respiratory infections.
- •Use of narcotics (e.g. oxycodone, methadone).
- •Any prior history of amitryptiline use.
- •Use of monoamine oxidase inhibitors (MAOIs) within the past 4 weeks (selegiline, phenelzine, tranylcypromine, isocarboxazid, rasagiline, phenelzine sulfate, selegiline hydrochloride, rasagiline mesylate, tranylcypromine sulfate).
- •History of urinary retention.
- •Any history of major depressive disorder.
- •Any prior history of allergy to a tricyclic antidepressant.
- •Current diagnosis of gastroesophageal reflux (GERD).
- •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).
研究组 & 干预措施
amitriptyline
Subjects in this arm will receive pills composed of amitryptline 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
Reflux Symptom Index
时间窗: 8 weeks
Reflux symptom index change in score after treatment Range possible: 0 to 45 Higher values indicate worse symptoms / outcomes
次要结局
- Voice Handicap Index(8 weeks)
- Side Effects(8 weeks)
- Lost to Follow up(8 weeks)
研究者
J Pieter Noordzij
BMC Attending Physician
Boston Medical Center