Study of Celebrex (Celecoxib) in Patients With Recurrent Respiratory Papillomatosis
Status:
Completed
Trial end date:
2015-01-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Northwell Health
Collaborators:
Eastern Virginia Medical School National Institute on Deafness and Other Communication Disorders (NIDCD) Sanford Health University of Alabama at Birmingham University of California, San Francisco University of Iowa Vanderbilt University Weill Medical College of Cornell University