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Efficacy Study of Botulinum Toxin (BOTOX) Injections to Treat Vocal Fold Granulomas

NCT01678053 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-03-28

No results posted yet for this study

Summary

Vocal process granulomas are inflammatory masses caused in part by vocal trauma that arise in the posterior aspect of the vocal folds and result in throat pain, difficulty swallowing, hoarseness, and globus sensation. Antireflux therapy treats most granulomas, but many are recalcitrant to this therapy or take months to years to resolve. Botulinum toxin injection into the thyroarytenoid muscle has been effectively employed for recalcitrant granuloma, but causes significant voice loss, occasional difficulty swallowing and, in our clinical experience, is associated with significant recurrence. The investigators propose injecting another muscle in the larynx called the interarytenoid muscle with botulinum toxin type A to maintain the benefit of injection with less loss of voice. The investigators have shown the effectiveness of this treatment in a small, retrospective analysis.

Conditions

  • Contact Ulcer of Vocal Folds
  • Granuloma of Vocal Cords
  • Granuloma, Laryngeal
  • Granuloma

Interventions

DRUG

onabotulinumtoxinA

Botulinum toxin A is injected into the larynx in order to treat vocal fold granulomas.

DRUG

omeprazole (proton pump inhibitor)

Standard therapy of anti-reflux medications using omeprazole or equivalent PPI.

Sponsors & Collaborators

  • Phillip Song, MD

    lead OTHER

Principal Investigators

  • Phillip Song, M.D. · Massachusetts Eye and Ear Infirmary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
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 NCT01678053 on ClinicalTrials.gov