Trial · NCT02434523
Trial of the Treatment of Chronic Laryngitis With Amitryptiline
NCT02434523, Phase 2, Phase 3, Terminated, Boston Medical Center; results first posted 2016-11-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of the Treatment of Chronic Laryngitis With Amitryptiline. Trials, record NCT02434523. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02434523
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of the Treatment of Chronic Laryngitis With Amitryptiline
- NCT number
- NCT02434523
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 30 participants, actual
- Lead sponsor
- Boston Medical Center
- Conditions
- Laryngeal Diseases, Chronic Laryngeal Neuropathy
- Interventions
- Amitriptyline, Placebo
- First posted
- 2015-05-05
- Last updated
- 2016-11-30
- Results first posted
- 2016-11-30
- Limitations and caveats
- Early termination leading to small numbers of subjects analyzed
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Voice Handicap Index | 8 weeks | Voice handicap index change in score after treatment Possible range: 0 to 40 Higher values indicate worse symptoms / outcomes |
| Secondary | Side Effects | 8 weeks | number of patients with side effects, type of side effects |
| Secondary | Lost to Follow up | 8 weeks |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Reflux Symptom Index | 8 weeks | Patients who completed treatment and post-treatment questionnaire | units on a scale | MEAN |
| SECONDARY | Voice Handicap Index | 8 weeks | units on a scale | MEAN | |
| SECONDARY | Side Effects | 8 weeks | participants | NUMBER | |
| SECONDARY | Lost to Follow up | 8 weeks | number of subjects in each arm who were lost to follow up | participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Reflux Symptom Index | Amitriptyline | -2.7 | Standard Deviation 7.1 | units on a scale | |
| Reflux Symptom Index | Placebo | 0.3 | Standard Deviation 12.0 | units on a scale | |
| Voice Handicap Index | Amitriptyline | 3.7 | Standard Deviation 6.1 | units on a scale | |
| Voice Handicap Index | Placebo | 0 | Standard Deviation 4.3 | units on a scale | |
| Side Effects | Amitriptyline | Dizziness | 4 | participants | |
| Side Effects | Placebo | Dizziness | 2 | participants | |
| Side Effects | Amitriptyline | Fatigue | 3 | participants | |
| Side Effects | Placebo | Fatigue | 1 | participants | |
| Side Effects | Amitriptyline | Dry mouth | 1 | participants | |
| Side Effects | Placebo | Dry mouth | 2 | participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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 | 15 | |
| Overall Study | STARTED | Placebo | 15 | |
| Overall Study | COMPLETED | Amitriptyline | 10 | |
| Overall Study | COMPLETED | Placebo | 9 | |
| Overall Study | NOT COMPLETED | Amitriptyline | 5 | |
| Overall Study | NOT COMPLETED | Placebo | 6 |
Source ClinicalTrials.gov
Adverse events2
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 | Adverse Effect | Nervous system disorders | Amitriptyline | 6 | 15 | 15 |
| other | Adverse Effect | Nervous system disorders | Placebo | 2 | 15 | 15 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Amitriptyline | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Amitriptyline | 6 | 15 |
| Total, other adverse events | Placebo | 2 | 15 |
| Total, serious adverse events | Amitriptyline | 0 | 15 |
| Total, serious adverse events | Placebo | 0 | 15 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Amitriptyline vs Placebo: Lost to Follow up | 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/NCT02434523
GET https://conductscience.org/api/trials/v1/NCT02434523/registered