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
Sponsor study identifier
interventional
110
2 countries
9
Study Start
January 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
December 2005
Date type not reportedThis date has not been verified as actual or estimated.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2005
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2003
Date type not reportedThis date has not been verified as actual or estimated.
September 28, 2005
Actual (reported)September 30, 2005
Actual (reported)December 2005
Date type not reportedThis date has not been verified as actual or estimated.
The primary objective of the study is to assess the effect of RK-0202 versus placebo on the incidence and severity of oral mucositis.
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.
UCLA Medical Center
Los Angeles, California, 90095, United States
H Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612, United States
Commonwealth ENT
Louisville, Kentucky, 40207, United States
University of Connecticutt
Farmington, Massachusetts, 06030, United States
Medical University of Ohio, Cancer Institute Ruppert Cancer Center
Toledo, Ohio, 43614, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Cross Cancer Institute
Edmonton, Alberta, T6G1Z2, Canada
Steve Sonis, DMD DMSc
Harvard, Oral Medicine, Infection & Immunology
Doug Peterson, DMD
University of Connecticutt Health Center
Guy Juillard, MD
University of California, Los Angeles
Mark Chambers, DMD MS
MD Anderson
First Submitted
September 28, 2005
First Posted
September 30, 2005
Study Start
January 2003
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
December 2005
Date type not reportedContact the study team to confirm eligibility.
Juravinski Cancer Center
Hamilton, Ontario, L8V5C2, Canada
University of Ottawa
Ottawa, Ontario, K1H1C4, Canada
Andy Trotti, MD
H. Lee Moffitt Cancer Center and Research Institute
John Feldmeier, DO
Medical University of Ohio
Samy El Sayed, MD
Ottawa Regional Cancer Centre
Rufus Scrimger, MD
Cross Cancer Institute, Edmonton, CA
Jim Wright, MD
Juravinski Cancer Centre Hamilton Health Sciences
Donald Welsh, MD
Commonwealth ENT, Louisville, KY
This date has not been verified as actual or estimated.
Last Updated
January 15, 2007
Record last verified: 2005-10
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Source: ClinicalTrials.gov.
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