Treatment of Chronic Laryngitis With Amitriptyline

Boston Medical Center (BMC)

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Laryngeal Diseases

Treatments: Drug: Amitriptyline; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02552225

H 34438

Details and patient eligibility

About

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

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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6 participants in 2 patient groups, including a placebo group

amitriptyline

Experimental group

Description:

Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)

Treatment:

Drug: Amitriptyline

placebo

Placebo Comparator group

Description:

Subjects in this arm will receive pills composed only of Avicel (cellulose filler)

Treatment:

Other: Placebo