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

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ClinicalTrials.gov Identifier: NCT01099891
Recruitment Status : Unknown
Verified August 2014 by Daewoong Pharmaceutical Co. LTD..
Recruitment status was:  Active, not recruiting
First Posted : April 8, 2010
Last Update Posted : August 4, 2014
Sponsor:
Information provided by:
Daewoong Pharmaceutical Co. LTD.

Brief 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

Condition or disease Intervention/treatment Phase
Stomatitis Drug: rhEGF Drug: Placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : March 2010
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: EGF Drug: rhEGF
rhEGF 50 μg/ml, spray type, twice a day

Placebo Comparator: Placebo Drug: Placebo
Placebo, Spray type, Twice a day




Primary Outcome Measures :
  1. Incidence of severe oral mucositis (RTOG garde 3 or 4) [ Time Frame: 5 weeks(at the point of receiving 50 Gy radiation) ]

Secondary Outcome Measures :
  1. Incidence and duration of ≥ grade 2, 3 (RTOG scale) oral mucositis [ Time Frame: 5 weeks(at the point of receiving 50 Gy radiation) ]
  2. Incidence and duration of ≥ grade 2, 3 (WHO scale) oral mucositis [ Time Frame: 5 weeks(at the point of receiving 50 Gy radiation) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Responsible Party: Sang-wook, Lee, Asan medical center
ClinicalTrials.gov Identifier: NCT01099891     History of Changes
Other Study ID Numbers: DW_EGF010P
First Posted: April 8, 2010    Key Record Dates
Last Update Posted: August 4, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Stomatitis
Mouth Diseases
Stomatognathic Diseases