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Trial of the Treatment of Chronic Laryngitis With Amitryptiline

NCT02434523 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-11-30

Study results available
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Summary

The study will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis.

Conditions

  • Laryngeal Diseases
  • Chronic Laryngeal Neuropathy

Interventions

DRUG

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

OTHER

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

Sponsors & Collaborators

  • American Laryngological Association

    collaborator OTHER

  • Boston Medical Center

    lead OTHER

Principal Investigators

  • J. Pieter Noordzij, MD · Boston Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02434523 on ClinicalTrials.gov