Chronic Laryngeal Neuropathy, Laryngeal Diseases
Conditions
Keywords
laryngeal sensory neuropathy
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.
Interventions
DRUGAmitriptyline
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
OTHERPlacebo
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
Sponsors
American Laryngological Association
Boston Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reflux Symptom Index | 8 weeks | Reflux symptom index change in score after treatment Range possible: 0 to 45 Higher values indicate worse symptoms / outcomes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Voice Handicap Index | 8 weeks | Voice handicap index change in score after treatment Possible range: 0 to 40 Higher values indicate worse symptoms / outcomes |
| Side Effects | 8 weeks | number of patients with side effects, type of side effects |
| Lost to Follow up | 8 weeks | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 15 |
| 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 | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Amitriptyline | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 3 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 12 Participants | 26 Participants |
| Age, Continuous | 45 years STANDARD_DEVIATION 15 | 50 years STANDARD_DEVIATION 14 | 48 years STANDARD_DEVIATION 15 |
| Reflux Symptom Index (RSI) Score | 19 severity on Likert-type scale STANDARD_DEVIATION 10 | 24 severity on Likert-type scale STANDARD_DEVIATION 10 | 22 severity on Likert-type scale STANDARD_DEVIATION 9 |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 5 Participants | 10 Participants | 15 Participants |
| Sex: Female, Male Male | 10 Participants | 5 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 15 | 2 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Reflux Symptom Index
Reflux symptom index change in score after treatment Range possible: 0 to 45 Higher values indicate worse symptoms / outcomes
Time frame: 8 weeks
Population: Patients who completed treatment and post-treatment questionnaire
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amitriptyline | Reflux Symptom Index | -2.7 units on a scale | Standard Deviation 7.1 |
| Placebo | Reflux Symptom Index | 0.3 units on a scale | Standard Deviation 12 |
Secondary
Lost to Follow up
Time frame: 8 weeks
Population: number of subjects in each arm who were lost to follow up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amitriptyline | Lost to Follow up | 5 participants |
| Placebo | Lost to Follow up | 6 participants |
Secondary
Side Effects
number of patients with side effects, type of side effects
Time frame: 8 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Amitriptyline | Side Effects | Dizziness | 4 participants |
| Amitriptyline | Side Effects | Fatigue | 3 participants |
| Amitriptyline | Side Effects | Dry mouth | 1 participants |
| Placebo | Side Effects | Dizziness | 2 participants |
| Placebo | Side Effects | Fatigue | 1 participants |
| Placebo | Side Effects | Dry mouth | 2 participants |
Secondary
Voice Handicap Index
Voice handicap index change in score after treatment Possible range: 0 to 40 Higher values indicate worse symptoms / outcomes
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amitriptyline | Voice Handicap Index | 3.7 units on a scale | Standard Deviation 6.1 |
| Placebo | Voice Handicap Index | 0 units on a scale | Standard Deviation 4.3 |