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Safety and Efficacy of RK0202 in Oral Mucositis

NCT00230191 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2007-01-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

RK-0202

Sponsors & Collaborators

  • RxKinetix

    lead INDUSTRY

Principal Investigators

  • 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

  • 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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Completion
2005-12-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00230191 on ClinicalTrials.gov