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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

April 6, 2010
August 1, 2014
March 2010
December 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01099891 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Clinical Study for Evaluation of Efficacy and Safety of EGF on Oral Mucositis in Radiation Therapy Patients
Not Provided

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

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Stomatitis
  • Drug: rhEGF
    rhEGF 50 μg/ml, spray type, twice a day
  • Drug: Placebo
    Placebo, Spray type, Twice a day
  • Experimental: EGF
    Intervention: Drug: rhEGF
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01099891
DW_EGF010P
Not Provided
Sang-wook, Lee, Asan medical center
Daewoong Pharmaceutical Co. LTD.
Not Provided
Not Provided
Daewoong Pharmaceutical Co. LTD.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP