Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Must be age 18 or older and able to consent for themselves 2. Must have had structural pathology such as tumor previously ruled out using flexible laryngoscopy 3. Must be able to speak and read the English language 4. Must have failed a 2 month or longer trial of a proton pump inhibitor for the treatment of gastro-esophageal reflux 5. 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 6. Potential subject and their physician have agreed that amitriptyline will be part of their regular care plan

Exclusion Criteria

  1. Active untreated environmental allergies 2. Smoking within past 5 years 3. Current upper respiratory infections 4. Use of narcotics (e.g. oxycodone, methadone) within the past week 5. Hypersensitivity to amitriptyline 6. 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. 7. 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) 8. History of urinary retention 9. History of an acute episode of a major depressive disorder within the past 12 months 10. 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) 11. Currently participating in another clinical trial that could interfere with the efficacy of, or participation in, this study. 12. Current untreated diagnosis of gastroesophageal reflux (GERD)

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
amitriptyline
Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)
  • Drug: Amitriptyline
    Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)
    Other names:
    • Elavil
Placebo Comparator
placebo
Subjects in this arm will receive pills composed only of Avicel (cellulose filler)
  • Other: Placebo
    Subjects in this arm will receive pills composed only of Avicel (cellulose filler)

More Details

Status
Terminated
Sponsor
Boston Medical Center

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.