Overview

This trial is active, not recruiting.

Condition stomatitis
Treatments rhegf, placebo
Phase phase 3
Sponsor Daewoong Pharmaceutical Co. LTD.
Start date March 2010
End date December 2015
Trial size 300 participants
Trial identifier NCT01099891, DW_EGF010P

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
rhegf
rhEGF 50 μg/ml, spray type, twice a day
(Placebo Comparator)
placebo
Placebo, Spray type, Twice a day

Primary Outcomes

Measure
Incidence of severe oral mucositis (RTOG garde 3 or 4)
time frame: 5 weeks(at the point of receiving 50 Gy radiation)

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Daewoong Pharmaceutical Co. LTD..