Trial of the Treatment of Chronic Laryngitis With Amitryptiline

Phase 2

Terminated

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

Detailed 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.

Recruitment & Eligibility

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).

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects in this arm will receive pills composed only of Avicel (cellulose filler)
amitriptyline	Amitriptyline	Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler)

Primary Outcome Measures

Name	Time	Method
Reflux Symptom Index	8 weeks	Reflux symptom index change in score after treatment Range possible: 0 to 45 Higher values indicate worse symptoms / outcomes

Secondary Outcome Measures

Name	Time	Method
Voice Handicap Index	8 weeks	Voice handicap index change in score after treatment Possible range: 0 to 40 Higher values indicate worse symptoms / outcomes
Side Effects	8 weeks	number of patients with side effects, type of side effects
Lost to Follow up	8 weeks