Treatment of Chronic Laryngitis With Amitriptyline

NCT02552225 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: H 34438
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Laryngeal Diseases

Keywords

laryngeal sensory neuropathy, chronic laryngeal neuropathy

Outcome Measures

Primary Outcomes (1)

• Change in Score on Reflux Symptom Index (RSI)

  The Reflux Symptom Index (RSI) is a validated questionnaire consisting of 9 statements to be ranked on a scale of 0-5 (0=no problem, 5=severe problem). RSI scores can range from 0 to 45, with higher scores correlated with more reflux symptoms.

  baseline, 8 weeks

Secondary Outcomes (6)

• Change in the Score on the Voice Handicap Index-10 (VHI-10)

  baseline, 8 weeks

• Change in the Score on the Cough Severity Index (CSI)

  baseline, 8 weeks

• Change in Throat Pain or Burning

  baseline, 8 weeks

• Change in Pain When Swallowing

  baseline, 8 weeks

• Subjective Improvement of Laryngitis Symptoms

  8 weeks

Study Arms (2)

amitriptyline

EXPERIMENTAL

Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)

Drug: Amitriptyline

placebo

PLACEBO COMPARATOR

Subjects in this arm will receive pills composed only of Avicel (cellulose filler)

Other: Placebo

Interventions

Amitriptyline DRUG

Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)

Also known as: Elavil

amitriptyline

Placebo OTHER

Subjects in this arm will receive pills composed only of Avicel (cellulose filler)

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Active untreated environmental allergies
• Smoking within past 5 years
• Current upper respiratory infections
• Use of narcotics (e.g. oxycodone, methadone) within the past week
• Hypersensitivity to amitriptyline
• 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.
• 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)
• History of urinary retention
• History of an acute episode of a major depressive disorder within the past 12 months
• 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)
• Currently participating in another clinical trial that could interfere with the efficacy of, or participation in, this study.
• Current untreated diagnosis of gastroesophageal reflux (GERD)

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Laryngeal Diseases

Interventions

Amitriptyline

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Limitations and Caveats

Funding was not obtained so the study could not be continued after the Covid pause.

Results Point of Contact

• Title: Pieter Noordzij, MD
• Organization: Boson Medical Center

pieter.noordzij@bmc.org

(617) 414-1756

Study Officials

• J. Pieter Noordzij, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: September 17, 2015
• Study Start: April 1, 2016
• Primary Completion: January 15, 2021
• Study Completion: January 15, 2021
• Last Updated: October 29, 2021
• Results First Posted: October 29, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)