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Treatment of Chronic Laryngitis With Amitriptyline

Primary Purpose

Laryngeal Diseases

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Amitriptyline

Placebo

About this trial

This is an interventional treatment trial for Laryngeal Diseases focused on measuring laryngeal sensory neuropathy, chronic laryngeal neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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)

Sites / Locations

Boston Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

amitriptyline

placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

The Voice Handicap Index-10 (VHI-10) is a 10-question scale rated from 0-4 that addresses effects on quality of life from voice disorders (0=never, 1=almost never, 2=sometimes, 3=almost always, 4=always). VHI-10 scores can range from 0 to 40, with lower scores correlated with a higher quality of life related to voice disorders.

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

The Cough Severity Index is a validated 10 item questionnaire to quantify a patient's symptoms associated with upper airway chronic cough. The 4 point Likert scale for each of the 10 items is 0 to 4 where 0 = Never, 1 = Almost never, 2 = Sometimes, 3 = Almost always, 4 = Always. Scores can range from 0 to 40 and higher scores reflect more coughing.

Change in Throat Pain or Burning

Participants will be asked to rate the severity of their "throat pain or burning" on a scale from 0 (no problem) to 5 (severe). Higher scores are correlated with more throat pain/burning.

Change in Pain When Swallowing

Participants were asked to rate their pain when swallowing on a scale of 0=none to 5= severe pain.

Subjective Improvement of Laryngitis Symptoms

Patients will subjectively rate improvement of symptoms on an ordinal 10-point scale where 0=no improvement and 10=significant improvement.

Number of Participants Who Dropped Out of the Study Due to Side Effects

The number of patients who report they did not continue with study participation due to side effects, will be obtained from study logs.

Full Information

NCT ID

NCT02552225

First Posted

September 9, 2015

Last Updated

October 1, 2021

Sponsor

Boston Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02552225

Brief Title

Treatment of Chronic Laryngitis With Amitriptyline

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Terminated

Why Stopped

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

Study Start Date

April 2016 (Actual)

Primary Completion Date

January 15, 2021 (Actual)

Study Completion Date

January 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boston Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Laryngeal Diseases

Keywords

laryngeal sensory neuropathy, chronic laryngeal neuropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

amitriptyline

Arm Type

Experimental

Arm Description

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

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Amitriptyline

Other Intervention Name(s)

Elavil

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Score on Reflux Symptom Index (RSI)

Description

Time Frame

baseline, 8 weeks

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

baseline, 8 weeks

Title

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

Description

Time Frame

baseline, 8 weeks

Title

Change in Throat Pain or Burning

Description

Participants will be asked to rate the severity of their "throat pain or burning" on a scale from 0 (no problem) to 5 (severe). Higher scores are correlated with more throat pain/burning.

Time Frame

baseline, 8 weeks

Title

Change in Pain When Swallowing

Description

Participants were asked to rate their pain when swallowing on a scale of 0=none to 5= severe pain.

Time Frame

baseline, 8 weeks

Title

Subjective Improvement of Laryngitis Symptoms

Description

Patients will subjectively rate improvement of symptoms on an ordinal 10-point scale where 0=no improvement and 10=significant improvement.

Time Frame

8 weeks

Title

Number of Participants Who Dropped Out of the Study Due to Side Effects

Description

The number of patients who report they did not continue with study participation due to side effects, will be obtained from study logs.

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

J. Pieter Noordzij, MD

Organizational Affiliation

Boston Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Boston Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Treatment of Chronic Laryngitis With Amitriptyline

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