NCT02552225

Treatment of Chronic Laryngitis With Amitriptyline

Double-blind Placebo Controlled Trial of the Treatment of Chronic Laryngitis With Amitriptyline

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Laryngeal Diseases

Interventions

Type	Name	Description
DRUG	Amitriptyline	Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)
OTHER	Placebo	Subjects in this arm will receive pills composed only of Avicel (cellulose filler)

Timeline

• Start date: 2016-04-01
• Primary completion: 2021-01-15
• Completion: 2021-01-15
• First posted: 2015-09-17
• Last updated: 2021-10-29
• Results posted: 2021-10-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study