UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015020 |
|---|---|
| Receipt number | R000017468 |
| Scientific Title | Effects of the indomethacin spray in patient with radiation-induced oral mucositis (Rondomised,double blind, placebo controlled crossover study) |
| Date of disclosure of the study information | 2014/09/30 |
| Last modified on | 2018/09/04 20:29:31 |
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Basic information
Public title
Effects of the indomethacin spray in patient with radiation-induced oral mucositis (Rondomised,double blind, placebo controlled crossover study)
Acronym
Effects of the indomethacin spray in patient with radiation-induced oral mucositis
Scientific Title
Effects of the indomethacin spray in patient with radiation-induced oral mucositis (Rondomised,double blind, placebo controlled crossover study)
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yoshimasa Kitagawa |
Organization
Department of oral pathobiological Science, Graduate school of dental medicine , Hokkaido University
Division name
Oral diagnosis and medicine
Zip code
Address
Kita13jyo Nishi7chome KIta-Ku Sapporo
TEL
0117064280
hata@den.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hironobu Hata |
Organization
Department of oral pathobiological Science, Graduate school of dental medicine , Hokkaido University
Division name
Oral diagnosis and medicine
Zip code
Address
Kita13jyo Nishi7chome KIta-Ku Sapporo
TEL
0117064280
Homepage URL
hata@den.hokudai.ac.jp
Sponsor or person
Institute
Graduate school of dental medicine , Hokkaido University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 02 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017468
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
