Treatment of Chronic Laryngitis With Amitriptyline (NCT02552225) | Clinical Trial Compass
TerminatedPhase 2/3
Treatment of Chronic Laryngitis With Amitriptyline
Stopped: Funding was not obtained so the study could not be continued after the Covid pause.
United States6 participantsStarted 2016-04
Plain-language summary
This randomized, double-blind, placebo-controlled trial will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)