Trial of the Treatment of Chronic Laryngitis With Amitryptiline

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

Detailed Description
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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.

Official Title
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Double-blind Placebo Controlled Trial of the Treatment of Chronic Laryngitis With Amitryptiline

Conditions
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Laryngeal Diseases, Chronic Laryngeal Neuropathy

Intervention / Treatment
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* Drug: Amitriptyline
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: amitriptyline<br>Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler) | Drug: Amitriptyline<br>* Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks<br>* Other names: treatment arm;|
| Placebo Comparator: Placebo<br>Subjects in this arm will receive pills composed only of Avicel (cellulose filler) | Other: Placebo<br>* Subjects in this arm will receive pills composed of only Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks<br>* Other names: placebo arm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reflux Symptom Index | Reflux symptom index change in score after treatment Range possible: 0 to 45 Higher values indicate worse symptoms / outcomes | 8 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laryngeal sensory neuropathy