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

Stomatitis Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01099891
• Other study ID #: DW_EGF010P
• Status: Active, not recruiting
• Phase: Phase 3
• First received: April 6, 2010
• Last updated: August 1, 2014
• Start date: March 2010
• Est. completion date: December 2015

Study information

• Verified date: August 2014
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stomatitis

Intervention

Drug:
• rhEGF
rhEGF 50 µg/ml, spray type, twice a day
• Placebo
Placebo, Spray type, Twice a day

Locations

Country	Name	City	State
Korea, Republic of	Asan medical center	Seoul
Korea, Republic of	Seoul National Colleage & Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of severe oral mucositis (RTOG garde 3 or 4)		5 weeks(at the point of receiving 50 Gy radiation)	No
Secondary	Incidence and duration of = grade 2, 3 (RTOG scale) oral mucositis		5 weeks(at the point of receiving 50 Gy radiation)	No
Secondary	Incidence and duration of = grade 2, 3 (WHO scale) oral mucositis		5 weeks(at the point of receiving 50 Gy radiation)	No