Clinical Trial: Safety and Efficacy of RK0202 in Oral Mucositis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 C

Brief 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 Summary: 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.
Sponsor: RxKinetix

Current Primary Outcome: The primary objective of the study is to assess the effect of RK-0202 versus placebo on the incidence and severity of oral mucositis.

Original Primary Outcome: Same as current

Current Secondary Outcome: The secondary objectives of the study are to assess the safety and tolerability of RK-0202 in these subjects and to explore whether the ProGelz™ vehicle alone is active in these subjects.

Original Secondary Outcome: Same as current

Information By: RxKinetix

Dates:
Date Received: September 28, 2005
Date Started: January 2003
Date Completion: December 2005
Last Updated: January 12, 2007
Last Verified: October 2005