Viewing Study NCT01195233


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Study NCT ID: NCT01195233
Status: COMPLETED
Last Update Posted: 2011-04-19
First Post: 2010-08-27
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Comparative Analysis of BioXtra on Xerostomia
Sponsor: Qazvin University Of Medical Sciences
Organization:

Study Overview

Official Title: Comparison Study of BioXtra Spray and Mouth Rinse in Patient With Radiation-induced Xerostomia
Status: COMPLETED
Status Verified Date: 2010-07
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: BioXtra
Brief Summary: The present study compared the efficacy of BioXtra spray and mouth rinse in the relief of radiotherapy-induced xerostomia in patients referred to Cancer Institute, Tehran Imam Khomeini Hospital.
Detailed Description: Xerostomia or dry mouth is an important complication of radiotherapy for head and neck regions producing serious discomfort for patients with a significant reduction in their quality of life. Symptomatic treatments for the disease include maintain oral hygiene and use of artificial saliva substitutes.

Due to limited studies on efficacy compounds BioXtra, present study compared the effects of spray and mouth rinse BioXtra in symptoms of xerostomia in patients under head and neck cancer radiotherapy .

Study Oversight

Has Oversight DMC: True
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?: