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

Sponsor

Daewoong Pharmaceutical Co. LTD. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01099891

Collaborator

(none)

300

Enrollment

Locations

Arms

Duration (Months)

150

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Stomatitis	Drug: rhEGF Drug: Placebo	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

Mar 1, 2010

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: EGF

Drug: rhEGF

rhEGF 50 μg/ml, spray type, twice a day

Placebo Comparator: Placebo

Drug: Placebo

Placebo, Spray type, Twice a day

Outcome Measures

Primary Outcome Measures

Incidence of severe oral mucositis (RTOG garde 3 or 4) [5 weeks(at the point of receiving 50 Gy radiation)]

Secondary Outcome Measures

Incidence and duration of ≥ grade 2, 3 (RTOG scale) oral mucositis [5 weeks(at the point of receiving 50 Gy radiation)]
Incidence and duration of ≥ grade 2, 3 (WHO scale) oral mucositis [5 weeks(at the point of receiving 50 Gy radiation)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan medical center	Seoul		Korea, Republic of
2	Seoul National Colleage & Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Daewoong Pharmaceutical Co. LTD.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01099891

Other Study ID Numbers:

DW_EGF010P

First Posted:

Apr 8, 2010

Last Update Posted:

Aug 4, 2014

Last Verified:

Aug 1, 2014

Additional relevant MeSH terms:

Stomatitis

Study Results

No Results Posted as of Aug 4, 2014