Back to resultsA Trial of Episil® Oral Liquid in Cancer Patients Suffering From Chemotherapy- and/or Radiation-induced Oral Mucositis
Primary Purpose
Chemotherapy- and/or Radiation-induced Oral Mucositis
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
episil®
Kang Su
Sponsored by
About this trial
This is an interventional supportive care trial for Chemotherapy- and/or Radiation-induced Oral Mucositis
Eligibility Criteria
Inclusion Criteria:
- Male/female patient 18 years of age;
- Pathological histologic and/or cytological diagnosis of malignant tumor;
- Patients who are suffering from symptomatic oral mucositis (WHO grade 2 or above) during chemotherapy and/or radiotherapy during screening period;
- Patients who are suffering from pain inside the oral cavity caused by oral mucositis, and pain assessment by Likert scale (0-10) results in a score of at least 6 out of 10 during screening period and at enrollment on Day 1;
- Patients undergoing chemotherapy and/or radiotherapy: patients must have received at least one cycle of multiple-cycle chemotherapy regimen and/or have received multiple doses of radiation, prior to the enrollment on Day 1;
- Patients at Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 and 3; and
- Patients are able to provide written informed consent to participate in the study freely after the nature of the study and disclosure of data has been explained to the patients.
Sites / Locations
- The People's Liberation Army 307 Hospital
- Fourth Hospital of Hebei Medical University
- Tongji Hospital
- Jiangsu Province Hospital
- The People's Liberation Army 81 Hospital
- The First Hospital of Jilin University
- Fudan University Shanghai Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
Outcomes
Primary Outcome Measures
Area under the curve (AUC) of pain score of oral mucositis
Oral mucosal pain is assessed by a numerical score (0-10 Likert-pain scale).
Secondary Outcome Measures
Pain intensity decrease inside the oral cavity
Oral mucosal pain is assessed by a numerical score (0-10 Likert-pain scale).
Peak pain intensity difference inside the oral cavity
Oral mucosal pain is assessed by a numerical score (0-10 Likert-pain scale).
Incidence of adverse events
Full Information
NCT ID
NCT03546985
First Posted
April 23, 2018
Last Updated
June 7, 2018
Sponsor
Solasia Pharma K.K.
Collaborators
Solasia Medical Information Consulting (Shanghai) Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03546985
Brief Title
A Trial of Episil® Oral Liquid in Cancer Patients Suffering From Chemotherapy- and/or Radiation-induced Oral Mucositis
Official Title
A Randomized, Multi-center, Single-use, Active-controlled, Open Study to Assess the Local Analgesic Effect of Episil® Oral Liquid in Cancer Patients Suffering From Chemotherapy- and/or Radiation-induced Oral Mucositis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
December 26, 2017 (Actual)
Primary Completion Date
May 8, 2018 (Actual)
Study Completion Date
May 25, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Solasia Pharma K.K.
Collaborators
Solasia Medical Information Consulting (Shanghai) Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a randomized, multi-center, single-use, active-controlled, two-stage open study of episil®. The purpose of this study is to assess the local analgesic effect of episil® in cancer patients suffering from chemotherapy- and/or radiation-induced oral mucositis, which will provide scientific and reliable clinical data in the product registration in China.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy- and/or Radiation-induced Oral Mucositis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Title
Group B
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
episil®
Intervention Description
Firmly press the pump and apply the stream of liquid to the oral cavity 3 times (a total volume of 0.45 mL approximately). Distribute to affected areas in the mouth, for example by using the tongue. Wait for 5 minutes for the protective film to form.
Intervention Type
Device
Intervention Name(s)
Kang Su
Other Intervention Name(s)
Generic of MuGard®
Intervention Description
Gently pour 5 mL of rinse into the mouth, keep the rinse staying in the oral cavity for at least 1 minute, and spilt out the liquid.
Primary Outcome Measure Information:
Title
Area under the curve (AUC) of pain score of oral mucositis
Description
Oral mucosal pain is assessed by a numerical score (0-10 Likert-pain scale).
Time Frame
During 6 hours after a single use of investigational medical device
Secondary Outcome Measure Information:
Title
Pain intensity decrease inside the oral cavity
Description
Oral mucosal pain is assessed by a numerical score (0-10 Likert-pain scale).
Time Frame
During 6 hours after a single use of investigational medical device
Title
Peak pain intensity difference inside the oral cavity
Description
Oral mucosal pain is assessed by a numerical score (0-10 Likert-pain scale).
Time Frame
During 6 hours after a single use of investigational medical device
Title
Incidence of adverse events
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male/female patient 18 years of age;
Pathological histologic and/or cytological diagnosis of malignant tumor;
Patients who are suffering from symptomatic oral mucositis (WHO grade 2 or above) during chemotherapy and/or radiotherapy during screening period;
Patients who are suffering from pain inside the oral cavity caused by oral mucositis, and pain assessment by Likert scale (0-10) results in a score of at least 6 out of 10 during screening period and at enrollment on Day 1;
Patients undergoing chemotherapy and/or radiotherapy: patients must have received at least one cycle of multiple-cycle chemotherapy regimen and/or have received multiple doses of radiation, prior to the enrollment on Day 1;
Patients at Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 and 3; and
Patients are able to provide written informed consent to participate in the study freely after the nature of the study and disclosure of data has been explained to the patients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xinchen Sun
Organizational Affiliation
Jiangsu People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guoyao Tang
Organizational Affiliation
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The People's Liberation Army 307 Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Fourth Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
The People's Liberation Army 81 Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Trial of Episil® Oral Liquid in Cancer Patients Suffering From Chemotherapy- and/or Radiation-induced Oral Mucositis
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