NCT00230191

Safety and Efficacy of RK0202 in Oral Mucositis

Phase II, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study of the Effects of RK-0202 on Oral Mucositis in Patients Receiving Radiation Therapy for Tumors of the Oral Cavity, Oropharynx, Nasopharynx, Salivary Glands or Supraglottic Region

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (planned)
• Sponsor: RxKinetix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to assess the effect of RK-0202 versus placebo on the incidence and severity of oral mucositis in subjects receiving radiation therapy for head and neck cancer. Concurrent chemotherapy is not allowed in the study.

Detailed description

Approximately 42,000 new cases of head and neck squamous cell carcinoma occur annually in the United States. Radiotherapy ("RT") plays a significant role in the management of head and neck cancer. The most common and clinically significant toxicities arising from head and neck radiation therapy are acute mucositis and acute and chronic xerostomia (dry mouth or salivary gland changes). In subjects receiving RT for cancers of the oral cavity or oropharynx the incidence of acute mucositis can exceed 90%. The painful ulceration of the oral mucosa produced by the radiation often leads to the requirement for narcotics to control pain, inability to eat, dehydration, the need for parenteral nutrition and, sometimes, breaks in RT. In addition to its symptomatic cost, the presence of mucositis has been associated with a number of other adverse outcomes including higher costs and more frequent hospitalizations.

Conditions

• Mouth Diseases
• Mouth Ulcers
• Oral Mucositis
• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	RK-0202

Timeline

• Start date: 2003-01-01
• Completion: 2005-12-01
• First posted: 2005-09-30
• Last updated: 2007-01-15

Locations

9 sites across 2 countries: United States, Canada