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Treatment of Chronic Laryngitis With Amitriptyline

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02552225
Recruitment Status : Suspended (Currently suspended due to covid-19 policies.)
First Posted : September 17, 2015
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Medical Center

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

Condition or disease Intervention/treatment Phase
Laryngeal Diseases Drug: Amitriptyline Other: Placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind Placebo Controlled Trial of the Treatment of Chronic Laryngitis With Amitriptyline
Actual Study Start Date : April 2016
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: amitriptyline
Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)
Drug: Amitriptyline
Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)
Other Name: Elavil

Placebo Comparator: placebo
Subjects in this arm will receive pills composed only of Avicel (cellulose filler)
Other: Placebo
Subjects in this arm will receive pills composed only of Avicel (cellulose filler)




Primary Outcome Measures :
  1. Score on Reflux Symptom Index (RSI) [ Time Frame: 10 weeks ]
    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).


Secondary Outcome Measures :
  1. Score on the Voice Handicap Index-10 (VHI-10) [ Time Frame: 10 weeks ]
    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).

  2. Score on the Cough Severity Index [ Time Frame: 10 weeks ]
    The Cough Severity Index is a validated questionnaire using a 10-item likert scale to quantify a patient's symptoms associated with upper airway chronic cough.

  3. Ancillary laryngitis symptom measures [ Time Frame: 10 weeks ]
    Two questions will ask subjects to rate the severity of their "throat pain or burning" and "pain with swallowing". These questions will be scored on a scale from 0 (no problem) to 5 (severe).

  4. Subjective improvement of laryngitis symptoms [ Time Frame: 10 weeks ]
    Patients will subjectively rate improvement of symptoms on an ordinal 10-point scale where 0=no improvement and 10=significant improvement.

  5. Assessment of side effects [ Time Frame: 10 weeks ]
    Number of patients who report side effects (and types of side effects), and number of patients who drop out due to side effects, by treatment arm



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Exclusion Criteria:

  1. 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. Any prior history of amitriptyline or other tricyclic antidepressant use - including pregabalin, gabapentin, baclofen, or other GABA analogues or inhibitors - for any medical condition (not limited to chronic laryngitis)
  6. Use of any other monoamine oxidase inhibitors (MAOIs) other than amitryptiline within the past 4 weeks (selegiline, phenelzine, tranylcypromine, isocarboxazid, rasagiline, phenelzine sulfate, selegiline hydrochloride, rasagiline mesylate, tranylcypromine sulfate)
  7. History of urinary retention
  8. Any history of major depressive disorder
  9. Any prior history of allergy to a tricyclic antidepressant
  10. Current untreated diagnosis of gastroesophageal reflux (GERD)
  11. 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)
  12. Currently participating in another clinical trial that could interfere with the efficacy of, or participation in, this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02552225


Locations
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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
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Principal Investigator: J. Pieter Noordzij, MD Boston Medical Center
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Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT02552225    
Other Study ID Numbers: H 34438
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Boston Medical Center:
laryngeal sensory neuropathy, chronic laryngeal neuropathy
Additional relevant MeSH terms:
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Laryngitis
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Amitriptyline
Amitriptyline, perphenazine drug combination
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants