Phase 4
N=19
Use of Cidofovir for Recurrent Respiratory Papillomatosis
Recurrent Respiratory Papillomatosis
Bottom Line
View on ClinicalTrials.gov: NCT00205374 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Change in Papilloma Severity — 13.2; 12; 3.7; 3.6 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Cidofovir (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 5+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Papilloma Severity |
13.2; 12; 3.7; 3.6; 2.7; 5.1 | — |
| SECONDARY 12-month Change in Voice Handicap Index (VHI) Score |
22; 32; 31; 42 | — |
Summary
Recurrent respiratory papillomatosis (RRP) is the most common benign neoplasm of the larynx in the pediatric population. The impact of the disease on patients and families can be tremendous due to the need for frequent treatment. It would be highly beneficial to develop effective medical therapies as adjunctive measures to surgical ablation with the goal of reducing the frequency of reoccurrence.
Eligibility Criteria
Inclusion Criteria
- 4 surgeries for RRP in last 12 months
Exclusion Criteria
- Renal insufficiency
- Nephrotoxic drugs in the last 7 days
- Sulfa allergies
- Currently treated with systemic or topical HPV chemotherapeutic agents
- Females of childbearing potential with a positive pregnancy test
- Women who are breast feeding
Data sourced from ClinicalTrials.gov (NCT00205374). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.