Trial · NCT02552225
Treatment of Chronic Laryngitis With Amitriptyline
NCT02552225, Phase 2, Phase 3, Terminated, Boston Medical Center; results first posted 2021-10-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Chronic Laryngitis With Amitriptyline. Trials, record NCT02552225. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02552225
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Chronic Laryngitis With Amitriptyline
- NCT number
- NCT02552225
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 6 participants, actual
- Lead sponsor
- Boston Medical Center
- Conditions
- Laryngeal Diseases
- Interventions
- Amitriptyline, Placebo
- First posted
- 2015-09-17
- Last updated
- 2021-10-29
- Results first posted
- 2021-10-29
- Limitations and caveats
- Funding was not obtained so the study could not be continued after the Covid pause.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Score on Reflux Symptom Index (RSI) | baseline, 8 weeks | 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. |
| Secondary | Change in the Score on the Voice Handicap Index-10 (VHI-10) | baseline, 8 weeks | 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. |
| Secondary | Change in the Score on the Cough Severity Index (CSI) | baseline, 8 weeks | 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. |
| Secondary | Change in Throat Pain or Burning | baseline, 8 weeks | 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. |
| Secondary | Change in Pain When Swallowing | baseline, 8 weeks | Participants were asked to rate their pain when swallowing on a scale of 0=none to 5= severe pain. |
| Secondary | Subjective Improvement of Laryngitis Symptoms | 8 weeks | Patients will subjectively rate improvement of symptoms on an ordinal 10-point scale where 0=no improvement and 10=significant improvement. |
| Secondary | Number of Participants Who Dropped Out of the Study Due to Side Effects | 8 weeks | The number of patients who report they did not continue with study participation due to side effects, will be obtained from study logs. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Score on Reflux Symptom Index (RSI) | baseline, 8 weeks | 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. | score on a scale | MEAN |
| SECONDARY | Change in the Score on the Voice Handicap Index-10 (VHI-10) | baseline, 8 weeks | 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. | units on a scale | MEAN |
| SECONDARY | Change in the Score on the Cough Severity Index (CSI) | baseline, 8 weeks | 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. | units on a scale | MEAN |
| SECONDARY | Change in Throat Pain or Burning | baseline, 8 weeks | 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. | units on a scale | MEAN |
| SECONDARY | Change in Pain When Swallowing | baseline, 8 weeks | 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. | units on a scale | MEAN |
| SECONDARY | Subjective Improvement of Laryngitis Symptoms | 8 weeks | 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. | units on a scale | MEAN |
| SECONDARY | Number of Participants Who Dropped Out of the Study Due to Side Effects | 8 weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Score on Reflux Symptom Index (RSI) | Amitriptyline | -2 | Standard Deviation 1.41 | score on a scale | |
| Change in Score on Reflux Symptom Index (RSI) | Placebo | -1.67 | Standard Deviation 2.08 | score on a scale | |
| Change in the Score on the Voice Handicap Index-10 (VHI-10) | Amitriptyline | 8.0 | Standard Deviation 11.31 | units on a scale | |
| Change in the Score on the Voice Handicap Index-10 (VHI-10) | Placebo | 2.67 | Standard Deviation 4.04 | units on a scale | |
| Change in the Score on the Cough Severity Index (CSI) | Amitriptyline | 10 | Standard Deviation 14.14 | units on a scale | |
| Change in the Score on the Cough Severity Index (CSI) | Placebo | 3.67 | Standard Deviation 5.51 | units on a scale | |
| Change in Throat Pain or Burning | Amitriptyline | 2.0 | Standard Deviation 2.83 | units on a scale | |
| Change in Throat Pain or Burning | Placebo | -1.33 | Standard Deviation 1.53 | units on a scale | |
| Change in Pain When Swallowing | Amitriptyline | 1.0 | Standard Deviation 4.24 | units on a scale | |
| Change in Pain When Swallowing | Placebo | 0.33 | Standard Deviation 1.53 | units on a scale |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Amitriptyline | 3 | |
| Overall Study | STARTED | Placebo | 3 | |
| Overall Study | COMPLETED | Amitriptyline | 2 | |
| Overall Study | COMPLETED | Placebo | 3 | |
| Overall Study | NOT COMPLETED | Amitriptyline | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events26
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cough | Respiratory, thoracic and mediastinal disorders | Amitriptyline | 1 | 3 | 1 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 3 | 0 |
| other | Dizziness | General disorders | Amitriptyline | 2 | 3 | 2 |
| other | Dizziness | General disorders | Placebo | 1 | 3 | 1 |
| other | Tachycardia | Cardiac disorders | Amitriptyline | 1 | 3 | 1 |
| other | Tachycardia | Cardiac disorders | Placebo | 0 | 3 | 0 |
| other | Chest pain | General disorders | Amitriptyline | 1 | 3 | 1 |
| other | Chest pain | General disorders | Placebo | 0 | 3 | 0 |
| other | Arm weakness | General disorders | Amitriptyline | 1 | 3 | 1 |
| other | Arm weakness | General disorders | Placebo | 0 | 3 | 0 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Amitriptyline | 0 | 3 |
| Total, all-cause mortality | Placebo | 0 | 3 |
| Total, other adverse events | Amitriptyline | 2 | 3 |
| Total, other adverse events | Placebo | 1 | 3 |
| Total, serious adverse events | Amitriptyline | 0 | 3 |
| Total, serious adverse events | Placebo | 0 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Amitriptyline vs Placebo: Number of Participants Who Dropped Out of the Study Due to Side Effects | Trial comparisons |
| Amitriptyline vs Placebo: deaths from any cause | Trial comparisons |
| Amitriptyline vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02552225
GET https://conductscience.org/api/trials/v1/NCT02552225/events?page=2