Study of Celebrex (Celecoxib) in Patients With Recurrent Respiratory Papillomatosis

Summary

This is a randomized double blind controlled study to determine if celebrex (celecoxib), a selective COX-2 inhibitor, can decrease the rate of recurrence in adult and pediatric patients with recurrent respiratory papillomatosis. All patients will be evaluated for disease severity at enrollment and at 3 month intervals for 30 months. After randomization, patients in the early treatment arm will begin celecoxib 6 months after enrollment. The delayed treatment arm will begin celecoxib 18 months after enrollment. All patients will receive celecoxib for 1 year. During the time that patients do not receive celecoxib, they will receive a placebo capsule with the same appearance. Follow-up visits will occur at three month intervals for the duration of the study.

Conditions

• Recurrent Respiratory Papillomatosis

Interventions

DRUG

celebrex (celecoxib)

Adults: 400 mg celebrex (celecoxib) daily Pediatrics: 100 mg celebrex (celecoxib) daily for weight between 12-25 kg or 200 mg Celebrex (celecoxib) daily for weight \>25 kg

DRUG

placebo

similar appearing capsules containing inert ingredients

Sponsors & Collaborators

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

  collaborator NIH

• University of Iowa

  collaborator OTHER

• Eastern Virginia Medical School

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• Vanderbilt University

  collaborator OTHER

• Sanford Health

  collaborator OTHER

• Weill Medical College of Cornell University

  collaborator OTHER

• Northwell Health

  lead OTHER

Principal Investigators

• Bettie M Steinberg, PhD · Long Island Jewish Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

2 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-02-29

Primary Completion

2015-01-31

Completion

2015-01-31

Countries

• United States

Study Locations