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Trial of the Treatment of Chronic Laryngitis With Amitryptiline

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ClinicalTrials.gov Identifier: NCT02434523
Recruitment Status : Terminated (concern regarding study design)
First Posted : May 5, 2015
Results First Posted : November 30, 2016
Last Update Posted : November 30, 2016
Sponsor:
Collaborator:
American Laryngological Association
Information provided by (Responsible Party):
J Pieter Noordzij, Boston Medical Center

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

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

Detailed Description:
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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind Placebo Controlled Trial of the Treatment of Chronic Laryngitis With Amitryptiline
Study Start Date : September 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: amitriptyline
Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler)
 Drug: Amitriptyline
Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
Other Name: treatment arm
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 of only Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
Other Name: placebo arm


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Side Effects [ Time Frame: 8 weeks ]
    number of patients with side effects, type of side effects

  3. Lost to Follow up [ Time Frame: 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 or older and able to consent for themselves.
  • Structural pathology such as tumor previously ruled out using flexible laryngoscopy.
  • Able to speak and read the English language.
  • Failed a trial of a proton pump inhibitor for the treatment of gastopharyngeal 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.

Exclusion Criteria:

  • Environmental allergies.
  • Smoking within past 5 years.
  • Using ginko bilboa (or unwilling to cease using it).
  • Current upper respiratory infections.
  • Use of narcotics (e.g. oxycodone, methadone).
  • Any prior history of amitryptiline use.
  • Use of monoamine oxidase inhibitors (MAOIs) within the past 4 weeks (selegiline, phenelzine, tranylcypromine, isocarboxazid, rasagiline, phenelzine sulfate, selegiline hydrochloride, rasagiline mesylate, tranylcypromine sulfate).
  • History of urinary retention.
  • Any history of major depressive disorder.
  • Any prior history of allergy to a tricyclic antidepressant.
  • Current diagnosis of gastroesophageal reflux (GERD).
  • 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).
Contacts and Locations
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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): NCT02434523


Locations
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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
American Laryngological Association
Investigators
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Principal Investigator: J. Pieter Noordzij, MD Boston Medical Center
More Information
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Responsible Party: J Pieter Noordzij, BMC Attending Physician, Boston Medical Center
ClinicalTrials.gov Identifier: NCT02434523     History of Changes
Other Study ID Numbers: H-29925
First Posted: May 5, 2015    Key Record Dates
Results First Posted: November 30, 2016
Last Update Posted: November 30, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: No plan to share individual data. Data in aggregate to be presented in national meeting and journal in otolaryngology
Keywords provided by J Pieter Noordzij, Boston Medical Center:
laryngeal sensory 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