NCT01099891

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2010

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 6, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 8, 2010

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 4, 2014

Status Verified

August 1, 2014

Enrollment Period

5.8 years

First QC Date

April 6, 2010

Last Update Submit

August 1, 2014

Conditions

Stomatitis

Outcome Measures

Primary Outcomes (1)

  • Incidence of severe oral mucositis (RTOG garde 3 or 4)

    5 weeks(at the point of receiving 50 Gy radiation)

Secondary Outcomes (2)

  • Incidence and duration of ≥ grade 2, 3 (RTOG scale) oral mucositis

    5 weeks(at the point of receiving 50 Gy radiation)

  • Incidence and duration of ≥ grade 2, 3 (WHO scale) oral mucositis

    5 weeks(at the point of receiving 50 Gy radiation)

Study Arms (2)

EGF

EXPERIMENTAL
Drug: rhEGF

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

rhEGFDRUG

rhEGF 50 μg/ml, spray type, twice a day

EGF
PlaceboDRUG

Placebo, Spray type, Twice a day

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, aged at least 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Asan medical center

Seoul, South Korea

Location

Seoul National Colleage & Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 6, 2010

First Posted

April 8, 2010

Study Start

March 1, 2010

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

August 4, 2014

Record last verified: 2014-08

Locations

KR(2)