Clinical trial · Interventional
Celebrex (Celecoxib) Treatment of Laryngeal Papilloma
Voice-preserving Treatment of Laryngeal Papilloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 03/01/2009,due to date close to termination of this funding/study period
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Laryngeal Papilloma | Laryngeal Squamous Papilloma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Celebrex | Drug | Celecoxib | ALIAS |
| CO2 laser or microsurgery | Procedure | — | UNRESOLVED |
| PDL | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PDL+Celebrex
- description
- endoscopic treatment with once-time PDL radiation at 6.0-8.0 J on laryngeal papilloma, followed by oral taking of 9-month Celebrex (100mg, BID), in 15 subjects
- interventionNames
- Drug: Celebrex
- Device: PDL
- type
- ACTIVE_COMPARATOR
- label
- standard surgery
- description
- once-time and routine surgery, with either of carbon dioxide (CO2) laser radiation at 10.0-20.0 W or "cold" surgery with microinstruments, in 15 subjects
- interventionNames
- Procedure: CO2 laser or microsurgery
Primary outcomes (1)
- measure
- Number of Case With Papilloma Recurrence During a 12-month Follow up
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18 to 64 years of age 2. with laryngeal papillomas requiring surgical treatment 3. willingness to participate in the study 4. a signed informed consent form Exclusion Criteria: 1. age less than 18 years 2. evidence of mental impairment so that the patient can not understand or sign the consent form 3. malignant diseases such as laryngeal cancer 4. established coronary heart and artery disorder, cerebrovascular disease, and other cardiovascular diseases 5. established diabetes, which requires (1) insulin treatment; or (2) more than 2 oral agents of medication; or (3) to have a baseline HgbA1c \>8.0 6. hypertension, with ongoing blood pressure \> 150 mg Hg systolic or to require medication 7. family history with serious cardiovascular events and problems 8. any sign and evidence which in the opinion of cardiovascular physician warrants exclusion of subject
References
Publications (0)
Data not yet available