Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00349024
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2006-07-05
Brief Title:
Polyvinylpyrrolidone-Sodium Hyaluronate Gel in Reducing Pain From Oral Mucositis in Young Patients With Cancer
Sponsor:
Childrens Cancer and Leukaemia Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Efficacy of Gelclair in Reducing the Pain of Oral Mucositis in Children and Young People With Cancer SC 2005 07
Status:
UNKNOWN
Status Verified Date:
2009-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
RATIONALE Polyvinylpyrrolidone-sodium hyaluronate gel may lessen the pain of oral mucositis or mouth sores in patients undergoing treatment for cancer
PURPOSE This clinical trial is studying how well polyvinylpyrrolidone-sodium hyaluronate gel works in reducing pain from oral mucositis in young patients with cancer
PURPOSE This clinical trial is studying how well polyvinylpyrrolidone-sodium hyaluronate gel works in reducing pain from oral mucositis in young patients with cancer
Detailed Description:
OBJECTIVES
Examine the feasibility and acceptability of polyvinylpyrrolidone-sodium hyaluronate gel in pediatric patients experiencing oral pain from mucositis after cancer therapy
OUTLINE This is a prospective uncontrolled open-label pilot multicenter study
Beginning before hospital discharge or day 3 after chemotherapy patients use oral polyvinylpyrrolidone-sodium hyaluronate gel mouth rinse for at least 1 minute 3 times per day or as needed Treatment continues for 48 hours Patients with persistent oral pain may continue treatment with polyvinylpyrrolidone-sodium hyaluronate gel beyond 48 hours
Oral pain and acceptability ie taste of polyvinylpyrrolidone-sodium hyaluronate gel are assessed periodically using self-reported rating scales
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
Examine the feasibility and acceptability of polyvinylpyrrolidone-sodium hyaluronate gel in pediatric patients experiencing oral pain from mucositis after cancer therapy
OUTLINE This is a prospective uncontrolled open-label pilot multicenter study
Beginning before hospital discharge or day 3 after chemotherapy patients use oral polyvinylpyrrolidone-sodium hyaluronate gel mouth rinse for at least 1 minute 3 times per day or as needed Treatment continues for 48 hours Patients with persistent oral pain may continue treatment with polyvinylpyrrolidone-sodium hyaluronate gel beyond 48 hours
Oral pain and acceptability ie taste of polyvinylpyrrolidone-sodium hyaluronate gel are assessed periodically using self-reported rating scales
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CCLG-SC-2005-07 | None | None | None |
| EU-20621 | None | None | None |