Back to resultsThe Clinical Study for Evaluation of Efficacy and Safety of EGF on Oral Mucositis in Radiation Therapy Patients
Primary Purpose
Stomatitis
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
rhEGF
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Stomatitis
Eligibility Criteria
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
Sites / Locations
- Asan medical center
- Seoul National Colleage & Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
EGF
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Incidence of severe oral mucositis (RTOG garde 3 or 4)
Secondary Outcome Measures
Incidence and duration of ≥ grade 2, 3 (RTOG scale) oral mucositis
Incidence and duration of ≥ grade 2, 3 (WHO scale) oral mucositis
Full Information
NCT ID
NCT01099891
First Posted
April 6, 2010
Last Updated
August 1, 2014
Sponsor
Daewoong Pharmaceutical Co. LTD.
1. Study Identification
Unique Protocol Identification Number
NCT01099891
Brief Title
The Clinical Study for Evaluation of Efficacy and Safety of EGF on Oral Mucositis in Radiation Therapy Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.
4. Oversight
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EGF
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
rhEGF
Intervention Description
rhEGF 50 μg/ml, spray type, twice a day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, Spray type, Twice a day
Primary Outcome Measure Information:
Title
Incidence of severe oral mucositis (RTOG garde 3 or 4)
Time Frame
5 weeks(at the point of receiving 50 Gy radiation)
Secondary Outcome Measure Information:
Title
Incidence and duration of ≥ grade 2, 3 (RTOG scale) oral mucositis
Time Frame
5 weeks(at the point of receiving 50 Gy radiation)
Title
Incidence and duration of ≥ grade 2, 3 (WHO scale) oral mucositis
Time Frame
5 weeks(at the point of receiving 50 Gy radiation)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Asan medical center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National Colleage & Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Clinical Study for Evaluation of Efficacy and Safety of EGF on Oral Mucositis in Radiation Therapy Patients
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