Clinical Trial: Trial of the Treatment of Chronic Laryngitis With Amitryptiline

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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

Detailed 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.
Sponsor: Boston Medical Center

Current Primary Outcome: Reflux Symptom Index [ Time Frame: 8 weeks ]

Reflux symptom index change in score after treatment Range possible: 0 to 45 Higher values indicate worse symptoms / outcomes


Original Primary Outcome:

  • voice handicap index [ Time Frame: 8 weeks ]
  • Reflux Symptom Index [ Time Frame: 8 weeks ]


Current Secondary Outcome:

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


Original Secondary Outcome:

  • side effects (number of patients with side effects, type of side effects) [ Time Frame: 8 weeks ]
    number of patients with side effects, type of side effects
  • rate of discontinuation [ Time Frame: 8 weeks ]


Information By: Boston Medical Center

Dates:
Date Received: April 22, 2015
Date Started: September 2013
Date Completion:
Last Updated: October 7, 2016
Last Verified: October 2016