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Double-blind Placebo Controlled Trial of the Treatment of Chronic Laryngitis With Amitriptyline
This randomized, double-blind, placebo-controlled trial will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Boston Medical Center
Boston, Massachusetts, United States
Start Date
April 1, 2016
Primary Completion Date
January 15, 2021
Completion Date
January 15, 2021
Last Updated
October 29, 2021
6
ACTUAL participants
Amitriptyline
DRUG
Placebo
OTHER
Lead Sponsor
Boston Medical Center
Data Source & Attribution
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