NCT03546985

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Solasia Pharma K.K. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chemotherapy- and/or Radiation-induced Oral Mucositis

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2017-12-26
• Primary completion: 2018-05-08
• Completion: 2018-05-25
• First posted: 2018-06-06
• Last updated: 2018-06-08

Locations

7 sites across 1 country: China