Trial of the Treatment of Chronic Laryngitis With Amitryptiline

Boston Medical Center (BMC)

Status and phase

Terminated

Phase 3

Phase 2

Conditions

Chronic Laryngeal Neuropathy

Laryngeal Diseases

Treatments

Other: Placebo

Drug: Amitriptyline

Study type

Interventional

Funder types

Other

Identifiers

NCT02434523

H-29925

Details and patient eligibility

About

The study will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis.

Full description

The study will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis. At the baseline visit, subjects will be assigned at random to amitriptyline or placebo which they will take for 8 weeks. Subjects will be seen in the clinic at baseline and at 8 weeks. Improvement will be measured using standardized symptom scales, and a self-reported subjective improvement percentage.

Enrollment

30 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18 or older and able to consent for themselves.
Structural pathology such as tumor previously ruled out using flexible laryngoscopy.
Able to speak and read the English language.
Failed a trial of a proton pump inhibitor for the treatment of gastopharyngeal 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.

Exclusion criteria

Environmental allergies.
Smoking within past 5 years.
Using ginko bilboa (or unwilling to cease using it).
Current upper respiratory infections.
Use of narcotics (e.g. oxycodone, methadone).
Any prior history of amitryptiline use.
Use of monoamine oxidase inhibitors (MAOIs) within the past 4 weeks (selegiline, phenelzine, tranylcypromine, isocarboxazid, rasagiline, phenelzine sulfate, selegiline hydrochloride, rasagiline mesylate, tranylcypromine sulfate).
History of urinary retention.
Any history of major depressive disorder.
Any prior history of allergy to a tricyclic antidepressant.
Current diagnosis of gastroesophageal reflux (GERD).
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).