Trial of the Treatment of Chronic Laryngitis With Amitryptiline

October 7, 2016 updated by: J Pieter Noordzij, Boston Medical Center

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

The study will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • placebo arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks
Side Effects
Time Frame: 8 weeks
number of patients with side effects, type of side effects
8 weeks
Lost to Follow up
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Medical Center

Collaborators

American Laryngological Association

Investigators

  • Principal Investigator: J. Pieter Noordzij, MD, Boston Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

April 22, 2015

First Submitted That Met QC Criteria

May 4, 2015

First Posted (Estimate)

May 5, 2015

Study Record Updates

Last Update Posted (Estimate)

November 30, 2016

Last Update Submitted That Met QC Criteria

October 7, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-29925

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

No plan to share individual data. Data in aggregate to be presented in national meeting and journal in otolaryngology

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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