Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00163280
Status:
COMPLETED
Last Update Posted:
2008-02-12
First Post:
2005-09-09
Brief Title:
Safety Tolerability and Efficacy of ATL-104 in Oral Mucositis
Sponsor:
Alizyme
Organization:
Alizyme
Study Overview
Official Title:
Randomised Double-Blind Placebo-Controlled Study of Orally Administered ATL-104 to Assess Safety Tolerance and Effect on Oral Mucositis in Patients Following Treatment With Chemotherapy and Peripheral Blood Stem Cell Transplant PBSCT
Status:
COMPLETED
Status Verified Date:
2008-02
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:
This purpose of this study is to investigate whether ATL-104 is safe and well tolerated and whether it shows evidence of efficacy in mucositis in patients undergoing PBSCT
Detailed Description:
Mucositis is a serious side effect of cancer therapy and Peripheral Blood Stem Cell Transplant PBSCT which requires appropriate and effective management Mucositis is a condition in which there is inflammation and ulceration of the mouth throat and gut caused by damage to the mucosal barrier induced by chemo- and radiotherapy Symptoms include pain nausea abdominal cramping and vomiting This study will investigate whether ATL-104 when administered as a swallowable mouthwash is safe and well tolerated in patients undergoing PBSCT and to investigate its potential to reduce the level of severity of mucositis associated with PBSCT
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