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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002130
Receipt No. R000002603
Scientific Title Examination of the effectiveness of the indomethacin spray for radiation oral mucositis
Date of disclosure of the study information 2009/07/01
Last modified on 2009/06/28

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Basic information
Public title Examination of the effectiveness of the indomethacin spray for radiation oral mucositis
Acronym Examination of the effectiveness of the indomethacin spray for radiation oral mucositis
Scientific Title Examination of the effectiveness of the indomethacin spray for radiation oral mucositis
Scientific Title:Acronym Examination of the effectiveness of the indomethacin spray for radiation oral mucositis
Region
Japan

Condition
Condition radiation oral mucositis
Classification by specialty
Oral surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the effectiveness of the analgesic effects on radiation oral mucositis of the indomethacin spray
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual Analogue Scale
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 Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 ~2011.3.31
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patient with oral cancer
Key exclusion criteria Contraindications patient to NSAIDs
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanori Shinohara
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Department of Oral and Maxillofacial Surgery
Zip code
Address Honjo 2-2-1, Kumamoto
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hidenao Ogi
Organization Kumamoto University
Division name Department of Oral and Maxillofacial Surgery
Zip code
Address
TEL 096-373-5288
Homepage URL
Email

Sponsor
Institute Graduate School of Medical Sciences, Kumamoto University,Department of Oral and Maxillofacial Surgery
Institute
Department

Funding Source
Organization Graduate School of Medical Sciences, Kumamoto University,Department of Oral and Maxillofacial Surgery
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2009 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2009 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 06 Month 28 Day
Last modified on
2009 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002603

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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