Title
Trial of the Treatment of Chronic Laryngitis With Amitryptiline
Double-blind Placebo Controlled Trial of the Treatment of Chronic Laryngitis With Amitryptiline
Phase
Phase 2/Phase 3Lead Sponsor
Boston UniversityStudy Type
InterventionalStatus
Terminated Results PostedIndication/Condition
Chronic Laryngeal Neuropathy ...Intervention/Treatment
amitriptyline ...Study Participants
30The study will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis.
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.
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
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
Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler)
Subjects in this arm will receive pills composed only of Avicel (cellulose filler)
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).
| Event Type | Organ System | Event Term | Amitriptyline | Placebo |
|---|
Reflux symptom index change in score after treatment Range possible: 0 to 45 Higher values indicate worse symptoms / outcomes
Voice handicap index change in score after treatment Possible range: 0 to 40 Higher values indicate worse symptoms / outcomes
number of patients with side effects, type of side effects
