NCT01099891

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stomatitis

Interventions

Type	Name	Description
DRUG	rhEGF	rhEGF 50 μg/ml, spray type, twice a day
DRUG	Placebo	Placebo, Spray type, Twice a day

Timeline

• Start date: 2010-03-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2010-04-08
• Last updated: 2014-08-04

Locations

2 sites across 1 country: South Korea