Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00051441
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2003-01-09
Brief Title:
Safety Efficacy Study of Benzydamine Oral Rinse for the Treatment of Oral Mucositis Mouth Sores Resulting From Radiation Therapy for Cancer of the Oral Cavity Oropharynx or Nasopharynx
Sponsor:
McNeil Consumer Specialty Pharmaceuticals a Division of McNeil-PPC Inc
Organization:
McNeil Consumer Specialty Pharmaceuticals a Division of McNeil-PPC Inc
Study Overview
Official Title:
A Double-Blind Randomized Vehicle-Controlled Study Comparing the Safety and Efficacy of Benzydamine HCl 015 Oral Rinse Including a Separate Open-Label Standard of Care Arm in Subjects With Radiation-Induced Mucositis
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare the effectiveness and safety of benzydamine hydrochloride 015 oral rinse to a vehicle oral rinse in the treatment of radiation-induced oral mucositis and to compare the care normally used for radiation-induced oral mucositis to vehicle oral rinse to ensure that the vehicle does not have detrimental effects on the oral mucosa
Detailed Description:
This is a multicenter double-blind randomized vehicle-controlled study including an open-label standard of care arm to determine the effectiveness and safety of benezydamine hydrochloride 015 oral rinse as compared with vehicle oral rinse and vehicle oral rinse as compared to the care normally used in the treatment of radiation-induced oral mucositis The hypotheses are that benzydamine hydrochloride 015 oral rinse is better than vehicle oral rinse as measured by the proportion of patients reaching a WHO mucositis score of 3 by 5500 cGy and vehicle is no worse than the standard of care as measured by the proportion of patients reaching a WHO mucositis score of 3 by 5500 cGy Patients receiving benzydamine hydrochloride 015 or vehicle double-blind oral rinses will place 15 mL in the mouth for 2 minutes gargling for a few seconds at the beginning and end of the rinse and then expectorate the entire dose Dosing with oral rinses will be every 2 - 3 hours while awake for a minimum of 4 times daily to a maximum of 8 times per day Double-blind oral rinses will continue daily throughout the duration of the subjects radiation treatment regimen plus 2 additional weeks
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