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

Not Applicable

Completed

• Conditions: Chemotherapy- and/or Radiation-induced Oral Mucositis
• Interventions: Device: Kang Su; Device: episil®

• Registration Number: NCT03546985
• Lead Sponsor: Solasia Pharma K.K.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-26
• Study First Submitted: 2018-04-23
• Primary Completion: 2018-05-08
• Study First Submitted QC: 2018-05-23
• Study Completion: 2018-05-25
• Status Verified: 2018-06
• Study First Posted: 2018-06-06
• Last Update Submitted: 2018-06-07
• Last Update Posted: 2018-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Kang Su	-
Group A	episil®	-

Primary Outcome Measures

Name	Time	Method
Area under the curve (AUC) of pain score of oral mucositis	During 6 hours after a single use of investigational medical device	Oral mucosal pain is assessed by a numerical score (0-10 Likert-pain scale).

Secondary Outcome Measures

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

Trial Locations

Locations (7)

The People's Liberation Army 307 Hospital; 🇨🇳 Beijing, Beijing, China

Fourth Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China

Jiangsu Province Hospital; 🇨🇳 Nanjing, Jiangsu, China

The People's Liberation Army 81 Hospital; 🇨🇳 Nanjing, Jiangsu, China

The First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China