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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT01099891
First received: April 6, 2010
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Stomatitis
Drug: rhEGF
Drug: Placebo
Phase 3

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

Further study details as provided by Daewoong Pharmaceutical Co. LTD.:

Primary Outcome Measures:
  • Incidence of severe oral mucositis (RTOG garde 3 or 4) [ Time Frame: 5 weeks(at the point of receiving 50 Gy radiation) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence and duration of ≥ grade 2, 3 (RTOG scale) oral mucositis [ Time Frame: 5 weeks(at the point of receiving 50 Gy radiation) ] [ Designated as safety issue: No ]
  • Incidence and duration of ≥ grade 2, 3 (WHO scale) oral mucositis [ Time Frame: 5 weeks(at the point of receiving 50 Gy radiation) ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: March 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EGF Drug: rhEGF
rhEGF 50 μg/ml, spray type, twice a day
Placebo Comparator: Placebo Drug: Placebo
Placebo, Spray type, Twice a day

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01099891

Locations
Korea, Republic of
Asan medical center
Seoul, Korea, Republic of
Seoul National Colleage & Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
  More Information

No publications provided

Responsible Party: Sang-wook, Lee, Asan medical center
ClinicalTrials.gov Identifier: NCT01099891     History of Changes
Other Study ID Numbers: DW_EGF010P
Study First Received: April 6, 2010
Last Updated: August 1, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Stomatitis
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 30, 2014