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Celebrex (Celecoxib) Treatment of Laryngeal Papilloma

NCT00592319 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2012-08-31

Study results available
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Summary

Respiratory recurrent papilloma (RRP) is one of the most common benign tumors. Surgical removal is the current management for RRP, but it is a very traumatic procedure, and often leads to permanent voice dysfunction. In this study, we will develop a new, combined RRP treatment with a pulsed dye laser (PDL) and Celebrex. We will determine if Celebrex, a newly developed inhibitor of cyclooxygenase (COX)-2, can provide a long-term inhibitory effect on RRP, therefore preventing RRP from recurring. This combined strategy, if successful in this proposed study, will provide a new and ideal "voice-preserving" therapy for RRP that will deliver long-term efficacy in managing RRP.

Conditions

  • Laryngeal Papilloma

Interventions

DRUG

Celebrex

oral taking of Celebrex (100 mg, BID) for 9 months

DEVICE

PDL

once time radiation on laryngeal papilloma with PDL , at 6.0-8.0 J

PROCEDURE

CO2 laser or microsurgery

once-time surgery to remove laryngeal papilloma

Sponsors & Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

    collaborator NIH

  • Boston University

    lead OTHER

Principal Investigators

  • Wang Zhi, M.D · Boston Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2009-07-31
Completion
2009-07-31

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 NCT00592319 on ClinicalTrials.gov