UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A preliminary study of the effects of episil(r) oral liquid on chemotherapy- and/or radiation-induced oral mucositis
Title of the study (Brief title)	A preliminary study of episil(r) oral liquid
Region	Japan

Condition
Condition	Chemotherapy- and/or radiation-induced oral mucositis
Classification by specialty	Dental medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To preliminarily assess the local analgesic effect, feeling of application and adverse event/ device deficiency of a new medical device, episil(r) oral liquid, on chemotherapy- and/or radiation-induced oral mucositis
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in the pain intensity in the oral cavity during 2 hours after a single application of episil(r) , assessed by numerical rating scale score
Key secondary outcomes	Feeling of application of episil(r) , use of rescue mediation, and the incidence of adverse events and device deficiencies

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	A single application of episil(R) oral liquid by 3 pump strokes (0.45 mL) to affected area
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients aged > 20 years of age at the date of obtaining informed consent 2) Patients who are suffering from oral mucositis due to chemotherapy and/or radiotherapy or conditioning regimens prior to a hematopoietic stem cell transplantation 3) Patients who are suffering from pain; caused by oral mucositis, at a maximum of continued pain and spike pain inside the oral cavity, assessed by Universal Pain Assessment Tool results in at least 5 of Likert scale (0~10) at the start of application of episil(r). 4) Patients at good performance status; eg., at Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 and 3.
Key exclusion criteria	1) Patients have severely injured area not due to oral mucositis 2) Patients who are known or suspected CNS tumor, metastasis or invasion to the CNS 3) Patients have started the rescue medications on Day 1 prior to the application of episil(r). 4) Patients have known allergy to any ingredient in episil(r) 5) Patients who are participating in other clinical trials 6) Female patients who are breast-feeding, pregnancy or planned pregnancy 7) Patients with considerable concern for compliance with the protocol, in the judgment of investigator
Target sample size	10

Research contact person
Name of lead principal investigator	Shin-ichiro Hiraoka
Organization	Osaka University Dental Hospital
Division name	1st Department of Oral and Maxillofacial Surgery
Address	1-8 Yamadaoka, Suita, Osaka, 565-0871 Japan
TEL	+81-6-6879-5111
Email	hiraoka@dent.osaka-u.ac.jp

Public contact
Name of contact person	Shin-ichiro Hiraoka
Organization	Osaka University Dental Hospital
Division name	1st Department of Oral and Maxillofacial Surgery
Address	1-8 Yamadaoka, Suita, Osaka, 565-0871 Japan
TEL	+81-6-6879-5111
Homepage URL
Email	hiraoka@dent.osaka-u.ac.jp

Sponsor
Institute	Osaka University Dental Hospital
Institute
Department

Funding Source
Organization	Solasia Pharma K.K.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 21 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 10 Month 13 Day
Anticipated trial start date	2017 Year 12 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 12 Month 21 Day
Last modified on	2017 Year 12 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034823