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NCT00592319 · ClinicalTrials.gov registry record · Phase 2
Celebrex (Celecoxib) Treatment of Laryngeal Papilloma
A Phase 2 study, sponsored by Boston University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT00592319: Clinical Trial Phase 2 study, sponsored by Boston University.
NCT00592319 is a Phase 2 study that was terminated before completion, run by Boston University. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00592319, a Phase 2 study, was terminated before completion, sponsored by Boston University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study 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.
Primary Outcome
Criteria for the recurrence: the site scoring \>4, plus visible lesion found in \>50% of the treated tissue area, after surgery Description: The caculation of the site scoring is based on a called Derkay's scoring system: to indicate how many anatomic site involved, from the 0 (the best)to 13 (the worst),among a total of 13 laryngeal sites such as epiglottis or right true vocal cords.
Interventions
- DRUG Celebrex
- DEVICE PDL
- PROCEDURE CO2 laser or microsurgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2005-05 |
| Est. Completion | 2009-07 |
| Phase | Phase 2 |
Why NCT00592319 stopped before completion
NCT00592319 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Celebrex is the first listed.
NCT00592319 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00592319 about?
NCT00592319 is a clinical study titled "Celebrex (Celecoxib) Treatment of Laryngeal Papilloma". 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 lase...
What is the current status of trial NCT00592319?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2005-05. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00592319?
The interventions under investigation include: Celebrex (DRUG), PDL (DEVICE), CO2 laser or microsurgery (PROCEDURE).
Who is sponsoring clinical trial NCT00592319?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00592319's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 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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