Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01099891
Other study ID # DW_EGF010P
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received April 6, 2010
Last updated August 1, 2014
Start date March 2010
Est. completion date December 2015

Study information

Verified date August 2014
Source Daewoong Pharmaceutical Co. LTD.
Contact n/a
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 300
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
rhEGF
rhEGF 50 µg/ml, spray type, twice a day
Placebo
Placebo, Spray type, Twice a day

Locations

Country Name City State
Korea, Republic of Asan medical center Seoul
Korea, Republic of Seoul National Colleage & Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of severe oral mucositis (RTOG garde 3 or 4) 5 weeks(at the point of receiving 50 Gy radiation) No
Secondary Incidence and duration of = grade 2, 3 (RTOG scale) oral mucositis 5 weeks(at the point of receiving 50 Gy radiation) No
Secondary Incidence and duration of = grade 2, 3 (WHO scale) oral mucositis 5 weeks(at the point of receiving 50 Gy radiation) No
See also
  Status Clinical Trial Phase
Completed NCT02229136 - Miracle Mouthwash Plus Hydrocortisone vs Prednisolone Mouth Rinse for Mouth Sores Caused by Everolimus Phase 2
Completed NCT02762019 - Laser for Oral Mucositis in Pediatric Onco-hematology Phase 3
Recruiting NCT02945878 - Predictive Factors of Acute Oral Mucositis Induced by Chemo-radiotherapy for Local Advanced Nasopharyngeal Carcinoma N/A
Recruiting NCT05878405 - Methylene Blue Mouthwash for the Treatment of Oral Mucositis Pain in Patients With Cancer Phase 3
Completed NCT00323518 - A Phase II Controlled Trial of Velafermin for Prevention of Oral Mucositis Phase 2
Terminated NCT02326675 - Cryotherapy in the Prevention of Chemotherapy-Induced Mucositis in Stem Cell Transplant N/A
Terminated NCT01092975 - Safety of Phenylephrine for Oral Mucositis Prevention Phase 1
Terminated NCT00031551 - Evaluation of Efficacy and Mechanisms of an Antiinflammatory Intervention for Chemotherapy Related Mucosal Injury Phase 2
Completed NCT00385515 - Efficacy of SNX-1012 in the Treatment of Oral Mucositis Phase 2
Completed NCT03200340 - EC-18 for Oral Mucositis in Patients With Concomitant Chemoirradiation Phase 2
Not yet recruiting NCT05323058 - The Use of Tulsi Extract for The Management of Oral Mucositis in Head & Neck Cancer Patients Undergoing Radiotherapy Phase 2
Completed NCT01837446 - Morphine Mouthwash for Management of Oral Mucositis in Patients With Head and Neck Cancer Phase 2/Phase 3
Completed NCT00104065 - Safety and Efficacy of CG53135-05 in the Prevention of Oral Mucositis in Patients Receiving Bone Marrow Transplant Phase 2
Completed NCT03469284 - MOM's PAIN (Methylene Blue for Oral Mucositis' PAIN) Phase 2
Not yet recruiting NCT03778008 - Recombinant Bovine Basic Fibroblast Growth Factor for the Treatment of Radiation Induced Oral Mucositis Phase 2
Terminated NCT00075023 - Effectiveness of Topical Thalidomide to Treat Chronic Graft-Versus-Host-Disease Related Stomatitis Phase 2
Not yet recruiting NCT05010928 - Using Tea-based Mouthwash Relieve Stomatitis and Oral Ulcers Phase 2
Completed NCT02407834 - Effectiveness of Hygiene Solutions on Denture Biofilm Phase 4
Active, not recruiting NCT00101582 - Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer Phase 3
Recruiting NCT06071637 - Low Power Laser Therapy As Prevention Of Oral Mucositis And Oropharyngeal Pain In Patients Undergoing Allogenetic HSCT Phase 3