NCT02434523

Trial of the Treatment of Chronic Laryngitis With Amitryptiline

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

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Laryngeal Diseases
• Chronic Laryngeal Neuropathy

Interventions

Type	Name	Description
DRUG	Amitriptyline	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
OTHER	Placebo	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

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2015-05-05
• Last updated: 2016-11-30
• Results posted: 2016-11-30

Locations

1 site across 1 country: United States