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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryReflux Symptom Index8 weeksReflux symptom index change in score after treatment Range possible: 0 to 45 Higher values indicate worse symptoms / outcomes
SecondaryVoice Handicap Index8 weeksVoice handicap index change in score after treatment Possible range: 0 to 40 Higher values indicate worse symptoms / outcomes
SecondarySide Effects8 weeksnumber of patients with side effects, type of side effects
SecondaryLost to Follow up8 weeks

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYReflux Symptom Index8 weeksPatients who completed treatment and post-treatment questionnaireunits on a scaleMEAN
SECONDARYVoice Handicap Index8 weeksunits on a scaleMEAN
SECONDARYSide Effects8 weeksparticipantsNUMBER
SECONDARYLost to Follow up8 weeksnumber of subjects in each arm who were lost to follow upparticipantsNUMBER

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Reflux Symptom IndexAmitriptyline-2.7Standard Deviation 7.1units on a scale
Reflux Symptom IndexPlacebo0.3Standard Deviation 12.0units on a scale
Voice Handicap IndexAmitriptyline3.7Standard Deviation 6.1units on a scale
Voice Handicap IndexPlacebo0Standard Deviation 4.3units on a scale
Side EffectsAmitriptylineDizziness4participants
Side EffectsPlaceboDizziness2participants
Side EffectsAmitriptylineFatigue3participants
Side EffectsPlaceboFatigue1participants
Side EffectsAmitriptylineDry mouth1participants
Side EffectsPlaceboDry mouth2participants

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDAmitriptyline15
Overall StudySTARTEDPlacebo15
Overall StudyCOMPLETEDAmitriptyline10
Overall StudyCOMPLETEDPlacebo9
Overall StudyNOT COMPLETEDAmitriptyline5
Overall StudyNOT COMPLETEDPlacebo6

Adverse events2

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherAdverse EffectNervous system disordersAmitriptyline61515
otherAdverse EffectNervous system disordersPlacebo21515

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityAmitriptyline
Total, all-cause mortalityPlacebo
Total, other adverse eventsAmitriptyline615
Total, other adverse eventsPlacebo215
Total, serious adverse eventsAmitriptyline015
Total, serious adverse eventsPlacebo015

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.

ComparisonSource
Amitriptyline vs Placebo: Lost to Follow upTrial comparisons
Amitriptyline vs Placebo: serious adverse eventsTrial 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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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