Ignite Creation Date:
2024-05-05 @ 11:13 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01283906
Status:
COMPLETED
Last Update Posted:
2013-09-12
First Post:
2011-01-25
Brief Title:
A Study to Evaluate the Efficacy of MuGard for the Amelioration of Oral Mucositis in Head and Neck Cancer Patients
Sponsor:
Access Pharmaceuticals Inc
Organization:
Access Pharmaceuticals Inc
Study Overview
Official Title:
A Randomized Double-blind Study to Evaluate the Efficacy of MuGard Mucoadhesive Oral Wound Rinse for the Amelioration of Oral Mucositis in Subjects Receiving Chemoradiation Therapy for the Treatment of Cancers of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2013-09
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:
MuGard
Brief Summary:
This study is a randomized double-blind sham-controlled two-arm study conducted in subjects receiving chemoradiation therapy for the treatment of head and neck cancer to assess the efficacy of MuGard The study will evaluate the ability of MuGard to reduce the symptoms of oral mucositis The study includes a treatment period of approximately 7 weeks depending on the subjects prescribed radiation plan
MuGard is a liquid that is classified as a medical device It is a hydrated polymer system oral hydrogel and is intended for the management of oral mucositisstomatitis When gently distributed within the mouth the mucoadhesive formulation results in the formation of a protective coating over the oral mucosa Subjects undergoing chemotherapy with radiation for the treatment of head and neck cancer are at high risk of developing oral mucositis as an adverse side-effect of cancer treatment MuGard was previously shown to reduce the incidence and severity of mucositis in head and neck cancer patients undergoing radiation therapy when compared with data from historical control groups The purpose of this study is to perform a direct comparison of the effectiveness of MuGard with a control group
MuGard is a liquid that is classified as a medical device It is a hydrated polymer system oral hydrogel and is intended for the management of oral mucositisstomatitis When gently distributed within the mouth the mucoadhesive formulation results in the formation of a protective coating over the oral mucosa Subjects undergoing chemotherapy with radiation for the treatment of head and neck cancer are at high risk of developing oral mucositis as an adverse side-effect of cancer treatment MuGard was previously shown to reduce the incidence and severity of mucositis in head and neck cancer patients undergoing radiation therapy when compared with data from historical control groups The purpose of this study is to perform a direct comparison of the effectiveness of MuGard with a control group
Detailed Description:
None
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