Phase 4
Completed N=19
Use of Cidofovir for Recurrent Respiratory Papillomatosis
Recurrent Respiratory Papillomatosis
Source: ClinicalTrials.gov NCT00205374 ↗
Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: Change in Papilloma Severity — 13.2; 12; 3.7; 3.6 scores on a scale
◆ Published Evidence
Highly cited
111citations · ~6 / year
Cidofovir efficacy in recurrent respiratory papillomatosis: a randomized, double-blind, placebo-controlled study.
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.
Linked Publications
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Cidofovir efficacy in recurrent respiratory papillomatosis: a randomized, double-blind, placebo-controlled study.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.