Oral mucositis refers to ulcerative lesions of the oral mucosa that occur due to radiation therapy given for treatment of head and neck cancer. These lesions are painful, compromise nutrition and quality of life and may necessitate interruptions in radiation therapy, thus adversely affecting cancer therapy outcomes. This study examined the use of an anti-inflammatory medicine to reduce pain and severity of oral mucositis.

Key Inclusion Criteria:

• Patients who will be receiving at least 5000 centigray (cGy) radiation therapy to at least 2 of 14 pre-defined areas in the oral cavity.
• Women of childbearing potential must agree to use a medically accepted form of contraception during the course of the study. Women of childbearing potential must have a documented negative pregnancy test within fourteen days of enrollment in the study.
• Patient's willing and able to provide written informed consent for the study.

Key Exclusion Criteria:

• Patients with known hypersensitivity to celecoxib or other COX-2 inhibitors.
• Patients who have experienced asthma, urticaria, or allergic-type reactions after taking salicylates (e.g. aspirin) or Non-steroidal anti-inflammatory drugs (NSAIDs).
• Patients who have demonstrated allergic-type reactions to sulfonamides.
• Patients with a history of gastric, esophageal, pyloric channel or duodenal ulcer disease or gastrointestinal bleeding.
• Patients with a history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis) or pancreatic disease.
• Patients with severe hepatic impairment.
• Patients with advanced renal disease.
• Patients with a significant bleeding disorder.
• Patients under the age of 18 or over the age of 75.
• Women who are pregnant or nursing.
• Patients with a history of thromboembolic events including myocardial infarction, pulmonary embolism, deep venous thrombosis, transient ischemic attack and ischemic cerebrovascular accident (stroke).
• Patients who have had coronary angioplasty, coronary artery bypass surgery or another cardiac revascularization procedure.
• Patients with a history of a cardiac arrhythmia requiring anti-arrhythmic therapy, angina pectoris or congestive heart failure.

Intent-to-treat analysis performed for 40 participants. Per-protocol analysis performed for the period in which individual participants were taking study medication (celecoxib or placebo).

Adverse event data was collected from the date of Informed Consent through 30 days after the last study intervention.

All events reported as serious adverse events resulted in hospitalization of the participant during the period of study participation. All adverse events were reviewed by an independent Data and Safety Monitoring Board (DSMB) and were determined to be unrelated to use of celecoxib.