The CCOP site initiation visit was successfully completed in July 2006, and the interrater reliability training was completed November 2, 2006. The CCOP was approved for subject recruitment in 2007. One patient has been recruited to the study at the Greenville, SC, CCOP. Written informed consent was obtained from this participant. Patient was randomized to receive either etanercept mouthwash or placebo, which was administered by protocol schedule. Stomatitis and oropharyngeal pain were measured and biological samples were collected per protocol. The subject chose to take himself off protocol on BMT day +4. All data and biological samples were received appropriately by the NINR Study Coordinating Center.

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Intramural Research (Z01)
Project #
1Z01NR000012-04
Application #
7735237
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
4
Fiscal Year
2008
Total Cost
$199,397
Indirect Cost
Name
National Institute of Nursing Research
Department
Type
DUNS #
City
State
Country
United States
Zip Code