Treatment of Chronic Laryngitis With Amitriptyline

• Status: Terminated
• Trial end date: 2021-01-15
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Medical Center
• Collaborator: American Laryngological Association
• Treatments: Amitriptyline; Amitriptyline, perphenazine drug combination

Criteria

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)