Back to resultsTrial of the Treatment of Chronic Laryngitis With Amitryptiline
Primary Purpose
Laryngeal Diseases, Chronic Laryngeal Neuropathy
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Amitriptyline
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Laryngeal Diseases focused on measuring laryngeal sensory neuropathy
Eligibility 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).
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 amitryptline and Avicel (cellulose filler)
Subjects in this arm will receive pills composed only of Avicel (cellulose filler)
Outcomes
Primary Outcome Measures
Reflux Symptom Index
Reflux symptom index change in score after treatment Range possible: 0 to 45 Higher values indicate worse symptoms / outcomes
Secondary Outcome Measures
Voice Handicap Index
Voice handicap index change in score after treatment Possible range: 0 to 40 Higher values indicate worse symptoms / outcomes
Side Effects
number of patients with side effects, type of side effects
Lost to Follow up
Full Information
NCT ID
NCT02434523
First Posted
April 22, 2015
Last Updated
October 7, 2016
Sponsor
Boston Medical Center
Collaborators
American Laryngological Association
1. Study Identification
Unique Protocol Identification Number
NCT02434523
Brief Title
Trial of the Treatment of Chronic Laryngitis With Amitryptiline
Official Title
Double-blind Placebo Controlled Trial of the Treatment of Chronic Laryngitis With Amitryptiline
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
concern regarding study design
Study Start Date
September 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Medical Center
Collaborators
American Laryngological Association
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngeal Diseases, Chronic Laryngeal Neuropathy
Keywords
laryngeal sensory neuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
amitriptyline
Arm Type
Experimental
Arm Description
Subjects in this arm will receive pills composed of amitryptline 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)
treatment arm
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
placebo arm
Intervention Description
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
Primary Outcome Measure Information:
Title
Reflux Symptom Index
Description
Reflux symptom index change in score after treatment Range possible: 0 to 45 Higher values indicate worse symptoms / outcomes
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Voice Handicap Index
Description
Voice handicap index change in score after treatment Possible range: 0 to 40 Higher values indicate worse symptoms / outcomes
Time Frame
8 weeks
Title
Side Effects
Description
number of patients with side effects, type of side effects
Time Frame
8 weeks
Title
Lost to Follow up
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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).
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
Undecided
IPD Sharing Plan Description
No plan to share individual data. Data in aggregate to be presented in national meeting and journal in otolaryngology
Learn more about this trial
Trial of the Treatment of Chronic Laryngitis With Amitryptiline
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