CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
celebrex (celecoxib) +1 moredrug
Likely dose
celebrex (celecoxib) 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00571701
NCT00571701Phase 2Completed

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

Northwell Health·interventional·Posted Dec 12, 2007·Updated May 15, 2017

In Brief

A Phase 2 clinical trial evaluating celebrex (celecoxib) and placebo for Recurrent Respiratory Papillomatosis. Completed, enrolled 50 participants across 7 sites.

Detailed 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.

Study Details

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 12, 2007
Enrollment StartFeb 1, 2008
Primary CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 18.6 years ago

Interventions

celebrex (celecoxib)drug

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

placebodrug

similar appearing capsules containing inert ingredients