Clinical Trial: Treatment of Chronic Laryngitis With Amitriptyline

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Boston Medical Center

Current Primary Outcome: Score on modified Reflux Symptom Index (RSI) [ Time Frame: 8 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Score on modified Voice Handicap Index-10 (VHI-10) [ Time Frame: 8 weeks ]
• Number of patients with side effects [ Time Frame: 8 weeks ]
• Number of patients discontinuing treatment due to side effects [ Time Frame: 8 weeks ]
• Subjective percentage improvement in symptoms [ Time Frame: 8 weeks ]
  Patients will subjectively rate improvement in symptoms by percentage comparing pre-treatment to post-treatment symptoms after 8 weeks
• Frequency of side effect by category [ Time Frame: 8 weeks ]
  patients will describe subjective side effects experienced, such as dry mouth, sedation, dizziness

Original Secondary Outcome: Same as current

Information By: Boston Medical Center

Dates:
Date Received: September 9, 2015
Date Started: April 2016
Date Completion: October 2018
Last Updated: October 7, 2016
Last Verified: October 2016