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NCT00571701 · ClinicalTrials.gov registry record · Phase 2
Study of Celebrex (Celecoxib) in Patients With Recurrent Respiratory Papillomatosis
A Phase 2 study, sponsored by Northwell Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT00571701: Completed Phase 2 study, sponsored by Northwell Health.
NCT00571701 is a Phase 2 study that has completed, run by Northwell Health. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00571701, a Phase 2 study, has completed, sponsored by Northwell Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study 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.
Primary Outcome
Change in mean growth rates during the last 3 months of the first treatment period compared to the mean values at baseline. Endoscopy and removal of all tumor was done every 3 months. Growth rate is calculated as the scored amount of papilloma recurrence in a 3 month period divided by the exact number of days since last endoscopy and removal of all tumor.
Interventions
- DRUG placebo
- DRUG celebrex (celecoxib)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2008-02 |
| Est. Completion | 2015-01 |
| Phase | Phase 2 |
What the finished NCT00571701 record still lists
NCT00571701 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00571701 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00571701 about?
NCT00571701 is a clinical study titled "Study of Celebrex (Celecoxib) in Patients With Recurrent Respiratory Papillomatosis". 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 a...
What is the current status of trial NCT00571701?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2008-02. Estimated completion is 2015-01.
What interventions are being tested in trial NCT00571701?
The interventions under investigation include: placebo (DRUG), celebrex (celecoxib) (DRUG).
Who is sponsoring clinical trial NCT00571701?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00571701's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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