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

Solasia Pharma

Status

Completed

Conditions

Chemotherapy- and/or Radiation-induced Oral Mucositis

Treatments

Device: episil®

Device: Kang Su

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT03546985

SP-0301

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.