Treatment of Chronic Laryngitis With Amitriptyline

Phase 2

Terminated

Conditions: Laryngeal Diseases

Interventions: Other: Placebo
Drug: Amitriptyline

Registration Number: NCT02552225

Lead Sponsor: Boston Medical Center

Brief Summary: This randomized, double-blind, placebo-controlled trial will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis.

Detailed Description: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 6

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	Subjects in this arm will receive pills composed only of Avicel (cellulose filler)
amitriptyline	Amitriptyline	Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)

Primary Outcome Measures

Name	Time	Method
Change in Score on Reflux Symptom Index (RSI)	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.

Secondary Outcome Measures

Name	Time	Method
Change in the Score on the Voice Handicap Index-10 (VHI-10)	baseline, 8 weeks	The Voice Handicap Index-10 (VHI-10) is a 10-question scale rated from 0-4 that addresses effects on quality of life from voice disorders (0=never, 1=almost never, 2=sometimes, 3=almost always, 4=always). VHI-10 scores can range from 0 to 40, with lower scores correlated with a higher quality of life related to voice disorders.
Change in the Score on the Cough Severity Index (CSI)	baseline, 8 weeks	The Cough Severity Index is a validated 10 item questionnaire to quantify a patient's symptoms associated with upper airway chronic cough. The 4 point Likert scale for each of the 10 items is 0 to 4 where 0 = Never, 1 = Almost never, 2 = Sometimes, 3 = Almost always, 4 = Always. Scores can range from 0 to 40 and higher scores reflect more coughing.
Change in Throat Pain or Burning	baseline, 8 weeks	Participants will be asked to rate the severity of their "throat pain or burning" on a scale from 0 (no problem) to 5 (severe). Higher scores are correlated with more throat pain/burning.
Change in Pain When Swallowing	baseline, 8 weeks	Participants were asked to rate their pain when swallowing on a scale of 0=none to 5= severe pain.
Subjective Improvement of Laryngitis Symptoms	8 weeks	Patients will subjectively rate improvement of symptoms on an ordinal 10-point scale where 0=no improvement and 10=significant improvement.
Number of Participants Who Dropped Out of the Study Due to Side Effects	8 weeks	The number of patients who report they did not continue with study participation due to side effects, will be obtained from study logs.