UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficiency and safety of indomethacin spray for the pain of oral mucositis in patients receiving chemotherapy.
Title of the study (Brief title)	The efficiency of indomethacin spray for the pain of oral mucositis in patients receiving chemotherapy.
Region	Japan

Condition
Condition	The pain of chemotherapy induced oral mucositis
Classification by specialty	Oral surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The object of this study is to evaluate the efficiency of indomethacin spray to oral mucositis pain in chemotherapy patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Analgesic effect of indomethacin spray and placebo for chemotherapy induced oral mucositis.
Key secondary outcomes

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	Medicine
Interventions/Control_1	Indomethacin spray
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) The patients with oral mucositis pain, and the doctor in charge judged use of indomethacin spray to be useful in pain control
Key exclusion criteria	1) Patient having serious comorbidities (a liver disease, renal disease, a heart trouble, blood disorder or metabolic disease). 2) A patient planning the use of the clinical experimental medicine or using. 3) The patient who is contraindicated to NSAIDs
Target sample size	60

Research contact person
Name of lead principal investigator	Hironobu Hata
Organization	Hokkkaido cancer center
Division name	Department of dental surgery
Address	Sapporo city Shiroishi-Ku Kikusui4-2 3-54
TEL	011-811-9111
Email	hatahiro@sap-cc.go.jp

Public contact
Name of contact person	Hironobu Hata
Organization	Hokkkaido cancer center
Division name	Department of dental surgery
Address	Sapporo city Shiroishi-Ku Kikusui4-2 3-54
TEL	011-811-9111
Homepage URL
Email	hatahiro@sap-cc.go.jp

Sponsor
Institute	Hokkkaido cancer center
Institute
Department

Funding Source
Organization	Hokkkaido cancer center department of clinical research
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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	2014 Year 12 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 01 Day
Anticipated trial start date	2015 Year 01 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 09 Month 04 Day

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

Management information
Registered date	2014 Year 12 Month 01 Day
Last modified on	2018 Year 09 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018402