A Trial of Episil® Oral Liquid in Cancer Patients Suffering From Chemotherapy- and/or Radiation-induced Oral Mucositis

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

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.

Study Overview

• Status: Completed
• Conditions: Chemotherapy- and/or Radiation-induced Oral Mucositis
• Intervention / Treatment: Device: episil®; Device: Kang Su

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • The People's Liberation Army 307 Hospital
  • Hebei
    • Shijiazhuang, Hebei, China
      • Fourth Hospital of Hebei Medical University
  • Hubei
    • Wuhan, Hubei, China
      • Tongji Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Jiangsu Province Hospital
    • Nanjing, Jiangsu, China
      • The People's Liberation Army 81 Hospital
  • Jilin
    • Changchun, Jilin, China
      • The First Hospital of Jilin University
  • Shanghai
    • Shanghai, Shanghai, China
      • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group A	Device: episil®; 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.
ACTIVE_COMPARATOR: Group B	Device: Kang Su; 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.; Other Names: Generic of MuGard®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	During 6 hours after a single use of investigational medical device

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity decrease inside the oral cavity	Oral mucosal pain is assessed by a numerical score (0-10 Likert-pain scale).	During 6 hours after a single use of investigational medical device
Peak pain intensity difference inside the oral cavity	Oral mucosal pain is assessed by a numerical score (0-10 Likert-pain scale).	During 6 hours after a single use of investigational medical device
Incidence of adverse events		2 days

Collaborators and Investigators

• Sponsor: Solasia Pharma K.K.
• Collaborators: Solasia Medical Information Consulting (Shanghai) Co. Ltd.
• Investigators: Principal Investigator: Xinchen Sun, Jiangsu People's Hospital; Principal Investigator: Guoyao Tang, Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 26, 2017
• Primary Completion (ACTUAL): May 8, 2018
• Study Completion (ACTUAL): May 25, 2018

Study Registration Dates

• First Submitted: April 23, 2018
• First Submitted That Met QC Criteria: May 23, 2018
• First Posted (ACTUAL): June 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 8, 2018
• Last Update Submitted That Met QC Criteria: June 7, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis; Stomatitis
• Other Study ID Numbers: SP-0301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No