Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00205374
Status:
COMPLETED
Last Update Posted:
2019-02-26
First Post:
2005-09-13
Brief Title:
Use of Cidofovir for Recurrent Respiratory Papillomatosis
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Use of Cidofovir Injection in the Treatment of Recurrent Respiratory Papillomatosis
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
The focus of the present study is to evaluate the usefulness of cidofovir injection in diminishing the frequency and magnitude of papilloma recurrences in adult and pediatric RRP patients Briefly patients will be randomized into either a treatment cidofovir injection or a placebo group The following measures will be made at each of 6 data collection time points over the course of one year 1 tumor load based upon a published staging system for papilloma 2 degree of respiratory obstruction for phonation as assessed by phonation threshold pressures and 3 general health on validated health inventories SF12 and Voice Handicap Index for adults PedsQL Trademarked for children and via measures of height weight and days absent from school or daycare where applicable for children A repeated measures analysis will allow examination of time by treatment interactions to determine if the cidofovir injection group has fewer or less severe recurrences than the placebo group
Specifically we will answer the following questions in this investigation
1 Does cidofovir injection reduce the frequency of RRP recurrences
2 Does cidofovir injection reduce the magnitude of RRP as assessed with a proposed staging system for RRP Derkay et al 1998 and measures of phonatory threshold pressure
3 Does cidofovir injection improve general health as assessed by height weight and days absent from school in pediatric patients and health inventories general health and voice-related in children and adults
Specifically we will answer the following questions in this investigation
1 Does cidofovir injection reduce the frequency of RRP recurrences
2 Does cidofovir injection reduce the magnitude of RRP as assessed with a proposed staging system for RRP Derkay et al 1998 and measures of phonatory threshold pressure
3 Does cidofovir injection improve general health as assessed by height weight and days absent from school in pediatric patients and health inventories general health and voice-related in children and adults
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None