UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of the indomethacin spray in patient with radiation-induced oral mucositis (Rondomised,double blind, placebo controlled crossover study)
Title of the study (Brief title)	Effects of the indomethacin spray in patient with radiation-induced oral mucositis
Region	Japan

Condition
Condition	Head and neck cancer patients with radiation induced oral mucositis
Classification by specialty	Dental medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Examine the efficacy of the indomethacin spray for radiation induced oral mucositis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	analgesic effect of the indomethacin spray for radiation induced oral mucositis (VAS after 30 minutes)
Key secondary outcomes	Safty of indomethacin spray for radiation induced oral mucositis

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	administration of indomethacin spray
Interventions/Control_2	administration of placebo
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)The patient of oropharyngeal cancer or maxillary or oral cancer. 2)The patient with oral mucositis (>Gr.1 NCI CTCAE Ver.3) and pain (>VAS50mm) 3)Indomethacin spray is available 4)Perfomance status(ECOG) 0 or 1. 5)Over 20 age (at the time of the agreement acquisition).
Key exclusion criteria	1)Patient with serious comorbidities. 2)Patient with Gr.2 or more mucositis but no pain. 3)During(or Planning of) the study of a clinical experimental medicine. 4)Contraindication of NSAIDs 5)Patient whom the chief physician or principal investigator judged to be inappropriate.
Target sample size	54

Research contact person
Name of lead principal investigator	Yoshimasa Kitagawa
Organization	Department of oral pathobiological Science, Graduate school of dental medicine , Hokkaido University
Division name	Oral diagnosis and medicine
Address	Kita13jyo Nishi7chome KIta-Ku Sapporo
TEL	0117064280
Email	hata@den.hokudai.ac.jp

Public contact
Name of contact person	Hironobu Hata
Organization	Department of oral pathobiological Science, Graduate school of dental medicine , Hokkaido University
Division name	Oral diagnosis and medicine
Address	Kita13jyo Nishi7chome KIta-Ku Sapporo
TEL	0117064280
Homepage URL
Email	hata@den.hokudai.ac.jp

Sponsor
Institute	Graduate school of dental medicine , Hokkaido University
Institute
Department

Funding Source
Organization	Graduate school of dental medicine , Hokkaido University
Organization
Division
Category of Funding Organization	Japanese Governmental office
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 09 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 02 Day
Anticipated trial start date	2014 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry	2018 Year 02 Month 28 Day
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	2014 Year 09 Month 02 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=R000017468