The Clinical Study for Evaluation of Efficacy and Safety of EGF on Oral Mucositis in Radiation Therapy Patients

August 1, 2014 updated by: Daewoong Pharmaceutical Co. LTD.
The purpose of this Study is to evaluate the efficacy and safety of rhEGF on oral mucositis in patients receiving the radiation therapy or the concurrent chemo-radiotherapy

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Radiation therapy causes many side effects especially oral mucositis. The purpose of this Study is to evaluate the efficacy and safety of rhEGF on oral mucositis in patients receiving the radiation therapy or the concurrent chemo-radiotherapy. Head and neck cancer patients who have a plan to receive a minimum of 50 Gy radiation therapy will be enrolled.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Seoul National Colleage & Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, aged at least 18 years

Exclusion Criteria:

  • Females who are pregnant, nursing, or planning a pregnancy during the study period or females of childbearing potential
  • Have oral mucositis or other oral conditions at study entry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo, Spray type, Twice a day
Experimental: EGF
Drug: rhEGF
rhEGF 50 μg/ml, spray type, twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of severe oral mucositis (RTOG garde 3 or 4)
Time Frame: 5 weeks(at the point of receiving 50 Gy radiation)
5 weeks(at the point of receiving 50 Gy radiation)

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence and duration of ≥ grade 2, 3 (RTOG scale) oral mucositis
Time Frame: 5 weeks(at the point of receiving 50 Gy radiation)
5 weeks(at the point of receiving 50 Gy radiation)
Incidence and duration of ≥ grade 2, 3 (WHO scale) oral mucositis
Time Frame: 5 weeks(at the point of receiving 50 Gy radiation)
5 weeks(at the point of receiving 50 Gy radiation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewoong Pharmaceutical Co. LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

April 6, 2010

First Submitted That Met QC Criteria

April 6, 2010

First Posted (Estimate)

April 8, 2010

Study Record Updates

Last Update Posted (Estimate)

August 4, 2014

Last Update Submitted That Met QC Criteria

August 1, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW_EGF010P

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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