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

Daewoong Pharmaceutical

Status and phase: Unknown; Phase 3

Conditions: Stomatitis

Treatments: Drug: Placebo; Drug: rhEGF

Study type: Interventional

Funder types: Industry

Identifiers

NCT01099891

DW_EGF010P

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups, including a placebo group

EGF

Experimental group

Treatment:

Drug: rhEGF

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo