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concern regarding study design
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| Name | Class |
|---|---|
| American Laryngological Association | OTHER |
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The study will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| amitriptyline | Experimental | Subjects in this arm will receive pills composed of amitryptline 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 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Reflux Symptom Index | Reflux symptom index change in score after treatment Range possible: 0 to 45 Higher values indicate worse symptoms / outcomes | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Voice Handicap Index | Voice handicap index change in score after treatment Possible range: 0 to 40 Higher values indicate worse symptoms / outcomes | 8 weeks |
| Side Effects | number of patients with side effects, type of side effects |
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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 |
No plan to share individual data. Data in aggregate to be presented in national meeting and journal in otolaryngology
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo | Subjects in this arm will receive pills composed only of 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 |
| 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 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Reflux Symptom Index | Reflux symptom index change in score after treatment Range possible: 0 to 45 Higher values indicate worse symptoms / outcomes | Patients who completed treatment and post-treatment questionnaire | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
1 year
Adverse event definitions used from http://www.fda.gov/downloads/Drugs/Guidances/ucm073122.pdf, Sections 1.2, 1.50, 1.60; http://www.fda.gov/downloads/Drugs/.../Guidances/UCM227351.pdf
Full definitions not listed due to character limit of 500
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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 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse Effect | Nervous system disorders | Non-systematic Assessment | Not an adverse event. Non-serious adverse effects include dizziness, fatigue, and dry mouth. |
Early termination leading to small numbers of subjects analyzed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jacob Pieter Noordzij | Boston Medical Center | 617-638-8124 | Pieter.Noordzij@bmc.org |
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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 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 |
|
|
| 8 weeks |
| Lost to Follow up | 8 weeks |
| BG001 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Reflux Symptom Index (RSI) Score | Mean | Standard Deviation | severity on Likert-type scale |
|
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
|
|
| Secondary | Voice Handicap Index | Voice handicap index change in score after treatment Possible range: 0 to 40 Higher values indicate worse symptoms / outcomes | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
|
| Secondary | Side Effects | number of patients with side effects, type of side effects | Posted | Number | participants | 8 weeks |
|
|
|
| Secondary | Lost to Follow up | number of subjects in each arm who were lost to follow up | Posted | Number | participants | 8 weeks |
|
|
|
| 0 |
| 15 |
| 6 |
| 15 |
| EG001 | 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 | 0 | 15 | 2 | 15 |
|
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| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| Dry mouth |
|