Clinical trial NCT02552225: Treatment of Chronic Laryngitis With Amitriptyline
Official title: Double-blind Placebo Controlled Trial of the Treatment of Chronic Laryngitis With Amitriptyline
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Laryngeal Diseases
Keywords: laryngeal sensory neuropathy, chronic laryngeal neuropathy
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2015-09-17
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, double-blind, placebo-controlled trial will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis.

Detailed description: Chronic laryngitis commonly manifests through symptoms including cough, hoarseness, throat clearing, foreign body sensation, throat pain, sensation of excessive phlegm, and difficulty swallowing. A significant minority also present with GERD, rhinosinusitis-induced post-nasal drainage, direct allergic effect, and smoking issues.

Amitriptyline is commonly used for mental/mood problems, but is also prescribed to treat chronic laryngitis because some investigators suggest a neuropathic etiology for idiopathic chronic laryngitis. No trials have compared any treatment for chronic laryngitis to placebo and it is unknown if currently used therapies for chronic laryngitis are effective.

At the baseline visit, subjects will be assigned at random to amitriptyline or placebo, which they will take for 4 weeks each. Subjects will be seen in the clinic at baseline and after 10 weeks. Improvement will be measured using standardized symptom scales, and a self-reported subjective improvement percentage.

Eligibility criteria: Inclusion Criteria:

1. Must be age 18 or older and able to consent for themselves
2. Must have had structural pathology such as tumor previously ruled out using flexible laryngoscopy
3. Must be able to speak and read the English language
4. Must have failed a 2 month or longer trial of a proton pump inhibitor for the treatment of gastro-esophageal reflux
5. 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
6. Potential subject and their physician have agreed that amitriptyline will be part of their regular care plan

Exclusion Criteria:

1. Active untreated environmental allergies
2. Smoking within past 5 years
3. Current upper respiratory infections
4. Use of narcotics (e.g. oxycodone, methadone) within the past week
5. Hypersensitivity to amitriptyline
6. History of amitriptyline use or of other tricyclic antidepressant - including pregabalin, gabapentin, baclofen, or other gamma-aminobutyric acid (GABA)analogues or inhibitors - for any medical condition (not limited to chronic laryngitis) within the past 12 months.
7. Use of any other monoamine oxidase inhibitors (MAOIs) other than amitriptyline within the past 4 weeks (selegiline, phenelzine, tranylcypromine, isocarboxazid, rasagiline, phenelzine sulfate, selegiline hydrochloride, rasagiline mesylate, tranylcypromine sulfate)
8. History of urinary retention
9. History of an acute episode of a major depressive disorder within the past 12 months
10. 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)
11. Currently participating in another clinical trial that could interfere with the efficacy of, or participation in, this study.
12. Current untreated diagnosis of gastroesophageal reflux (GERD)

Primary outcomes:
measure: Change in Score on Reflux Symptom Index (RSI)
timeFrame: baseline, 8 weeks
Secondary outcomes:
measure: Change in the Score on the Voice Handicap Index-10 (VHI-10)
timeFrame: baseline, 8 weeks
measure: Change in the Score on the Cough Severity Index (CSI)
timeFrame: baseline, 8 weeks
measure: Change in Throat Pain or Burning
timeFrame: baseline, 8 weeks
measure: Change in Pain When Swallowing
timeFrame: baseline, 8 weeks
measure: Subjective Improvement of Laryngitis Symptoms
timeFrame: 8 weeks
measure: Number of Participants Who Dropped Out of the Study Due to Side Effects
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: J. Pieter Noordzij, MD
role: PRINCIPAL_INVESTIGATOR
References: