Unique ID issued by UMIN | UMIN000030504 |
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Receipt number | R000034823 |
Scientific Title | A preliminary study of the effects of episil(r) oral liquid on chemotherapy- and/or radiation-induced oral mucositis |
Date of disclosure of the study information | 2017/12/21 |
Last modified on | 2017/12/21 14:26:32 |
A preliminary study of the effects of episil(r) oral liquid on chemotherapy- and/or radiation-induced oral mucositis
A preliminary study of episil(r) oral liquid
A preliminary study of the effects of episil(r) oral liquid on chemotherapy- and/or radiation-induced oral mucositis
A preliminary study of episil(r) oral liquid
Japan |
Chemotherapy- and/or radiation-induced oral mucositis
Dental medicine |
Malignancy
NO
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
Safety
Exploratory
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
Feeling of application of episil(r) , use of rescue mediation, and the incidence of adverse events and device deficiencies
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
A single application of episil(R) oral liquid by 3 pump strokes (0.45 mL) to affected area
20 | years-old | <= |
Not applicable |
Male and Female
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.
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
10
1st name | |
Middle name | |
Last name | Shin-ichiro Hiraoka |
Osaka University Dental Hospital
1st Department of Oral and Maxillofacial Surgery
1-8 Yamadaoka, Suita, Osaka, 565-0871 Japan
+81-6-6879-5111
hiraoka@dent.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Shin-ichiro Hiraoka |
Osaka University Dental Hospital
1st Department of Oral and Maxillofacial Surgery
1-8 Yamadaoka, Suita, Osaka, 565-0871 Japan
+81-6-6879-5111
hiraoka@dent.osaka-u.ac.jp
Osaka University Dental Hospital
Solasia Pharma K.K.
Profit organization
Japan
NO
2017 | Year | 12 | Month | 21 | Day |
Unpublished
Enrolling by invitation
2017 | Year | 10 | Month | 13 | Day |
2017 | Year | 12 | Month | 20 | Day |
2017 | Year | 12 | Month | 21 | Day |
2017 | Year | 12 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034823
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