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Funding was not obtained so the study could not be continued after the Covid pause.
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This randomized, double-blind, placebo-controlled trial will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| amitriptyline | Experimental | Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler) |
|
| placebo | Placebo Comparator | Subjects in this arm will receive pills composed only of Avicel (cellulose filler) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amitriptyline | Drug | Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Score on Reflux Symptom Index (RSI) | 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). RSI scores can range from 0 to 45, with higher scores correlated with more reflux symptoms. | baseline, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Score on the Voice Handicap Index-10 (VHI-10) | 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). VHI-10 scores can range from 0 to 40, with lower scores correlated with a higher quality of life related to voice disorders. | baseline, 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J. Pieter Noordzij, MD | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Amitriptyline | Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler) Amitriptyline: Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler) |
| FG001 | Placebo | Subjects in this arm will receive pills composed only of Avicel (cellulose filler) Placebo: Subjects in this arm will receive pills composed only of Avicel (cellulose filler) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Amitriptyline | Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler) Amitriptyline: Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler) |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Score on Reflux Symptom Index (RSI) | 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). RSI scores can range from 0 to 45, with higher scores correlated with more reflux symptoms. | There was no 8 week RSI score for the participant who withdrew from the amitriptyline arm so the change in score could not be calculated. | Posted | Mean | Standard Deviation | score on a scale | baseline, 8 weeks |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Amitriptyline | Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler) Amitriptyline: Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
Funding was not obtained so the study could not be continued after the Covid pause.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pieter Noordzij, MD | Boson Medical Center | (617) 414-1756 | pieter.noordzij@bmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 30, 2017 | Aug 13, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007818 | Laryngeal Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000639 | Amitriptyline |
| ID | Term |
|---|---|
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Placebo | Other | Subjects in this arm will receive pills composed only of Avicel (cellulose filler) |
|
| Change in the Score on the Cough Severity Index (CSI) | The Cough Severity Index is a validated 10 item questionnaire to quantify a patient's symptoms associated with upper airway chronic cough. The 4 point Likert scale for each of the 10 items is 0 to 4 where 0 = Never, 1 = Almost never, 2 = Sometimes, 3 = Almost always, 4 = Always. Scores can range from 0 to 40 and higher scores reflect more coughing. | baseline, 8 weeks |
| Change in Throat Pain or Burning | Participants will be asked to rate the severity of their "throat pain or burning" on a scale from 0 (no problem) to 5 (severe). Higher scores are correlated with more throat pain/burning. | baseline, 8 weeks |
| Change in Pain When Swallowing | Participants were asked to rate their pain when swallowing on a scale of 0=none to 5= severe pain. | baseline, 8 weeks |
| Subjective Improvement of Laryngitis Symptoms | Patients will subjectively rate improvement of symptoms on an ordinal 10-point scale where 0=no improvement and 10=significant improvement. | 8 weeks |
| Number of Participants Who Dropped Out of the Study Due to Side Effects | The number of patients who report they did not continue with study participation due to side effects, will be obtained from study logs. | 8 weeks |
Subjects in this arm will receive pills composed only of Avicel (cellulose filler) Placebo: Subjects in this arm will receive pills composed only of Avicel (cellulose filler) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Reflux Symptom Index (RSI) | 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). RSI scores can range from 0 to 45 with higher scores correlated with more reflux symptoms. | Mean | Standard Deviation | score on a scale |
|
| Voice Handicap Index-10 (VHI-10) | 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). VHI-10 scores can range from 0 to 40, with lower scores correlated with a higher quality of life related to voice disorders. | Mean | Standard Deviation | units on a scale |
|
| Cough Severity Index (CSI) | The Cough Severity Index is a validated 10 item questionnaire to quantify a patient's symptoms associated with upper airway chronic cough. The 4 point Likert scale for each of the 10 items is 0 to 4 where 0 = Never, 1 = Almost never, 2 = Sometimes, 3 = Almost always, 4 = Always. Scores can range from 0 to 40 and higher scores reflect more coughing. | Mean | Standard Deviation | units on a scale |
|
| Throat pain/burning | Participants will be asked to rate the severity of their "throat pain or burning" on a scale from 0 (no problem) to 5 (severe). Higher scores are correlated with more throat pain/burning. | Mean | Standard Deviation | units on a scale |
|
| Pain when swallowing | Participants were asked to rate their pain when swallowing on a scale of 0=none to 5= severe pain. | Mean | Standard Deviation | units on a scale |
|
| Placebo |
Subjects in this arm will receive pills composed only of Avicel (cellulose filler) Placebo: Subjects in this arm will receive pills composed only of Avicel (cellulose filler) |
|
|
| Secondary | Change in the Score on the Voice Handicap Index-10 (VHI-10) | 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). VHI-10 scores can range from 0 to 40, with lower scores correlated with a higher quality of life related to voice disorders. | There was no 8 week VHI-10 score for the participant who withdrew from the amitriptyline arm so the change in score could not be calculated. | Posted | Mean | Standard Deviation | units on a scale | baseline, 8 weeks |
|
|
|
| Secondary | Change in the Score on the Cough Severity Index (CSI) | The Cough Severity Index is a validated 10 item questionnaire to quantify a patient's symptoms associated with upper airway chronic cough. The 4 point Likert scale for each of the 10 items is 0 to 4 where 0 = Never, 1 = Almost never, 2 = Sometimes, 3 = Almost always, 4 = Always. Scores can range from 0 to 40 and higher scores reflect more coughing. | There was no 8 week CSI score for the participant who withdrew from the amitriptyline arm so the change in score could not be calculated. | Posted | Mean | Standard Deviation | units on a scale | baseline, 8 weeks |
|
|
|
| Secondary | Change in Throat Pain or Burning | Participants will be asked to rate the severity of their "throat pain or burning" on a scale from 0 (no problem) to 5 (severe). Higher scores are correlated with more throat pain/burning. | There was no 8 week assessment of throat pain/burning for the participant who withdrew from the amitriptyline arm, so the change in score could not be calculated. | Posted | Mean | Standard Deviation | units on a scale | baseline, 8 weeks |
|
|
|
| Secondary | Change in Pain When Swallowing | Participants were asked to rate their pain when swallowing on a scale of 0=none to 5= severe pain. | There was no 8 week assessment of pain while swallowing for the participant who withdrew from the amitriptyline arm, so the change in score could not be calculated. | Posted | Mean | Standard Deviation | units on a scale | baseline, 8 weeks |
|
|
|
| Secondary | Subjective Improvement of Laryngitis Symptoms | Patients will subjectively rate improvement of symptoms on an ordinal 10-point scale where 0=no improvement and 10=significant improvement. | There was no 8 week assessment of subjective assessment of laryngitis symptoms for the participant who withdrew from the amitriptyline arm, so it could ot be reported. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
|
| Secondary | Number of Participants Who Dropped Out of the Study Due to Side Effects | The number of patients who report they did not continue with study participation due to side effects, will be obtained from study logs. | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 2 |
| 3 |
| EG001 | Placebo | Subjects in this arm will receive pills composed only of Avicel (cellulose filler) Placebo: Subjects in this arm will receive pills composed only of Avicel (cellulose filler) | 0 | 3 | 0 | 3 | 1 | 3 |
| Dizziness | General disorders | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Chest pain | General disorders | Non-systematic Assessment |
|
| Arm weakness | General disorders | Non-systematic Assessment |
|
| Facial weakness | General disorders | Non-systematic Assessment |
|
| Indigestion | Gastrointestinal disorders | Non-systematic Assessment |
|
| Insomnia | General disorders | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Lack of energy | General disorders | Non-systematic Assessment |
|
| Sleepy | General disorders | Non-systematic Assessment |
|
| Dry mouth | General disorders | Non-systematic Assessment |
|
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| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |