UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011759 |
|---|---|
| Receipt number | R000013750 |
| Scientific Title | Effects of allopurinol mouthwash and rebamipide gargle for stomatitis occurred during radiation therapy for cancer and cancer chemotherapy |
| Date of disclosure of the study information | 2013/09/13 |
| Last modified on | 2013/09/13 20:23:17 |
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Basic information
Public title
Effects of allopurinol mouthwash and rebamipide gargle for stomatitis occurred during radiation therapy for cancer and cancer chemotherapy
Acronym
Effects of allopurinol mouthwash and rebamipide gargle for stomatitis
Scientific Title
Effects of allopurinol mouthwash and rebamipide gargle for stomatitis occurred during radiation therapy for cancer and cancer chemotherapy
Scientific Title:Acronym
Effects of allopurinol mouthwash and rebamipide gargle for stomatitis
Region
| Japan |
Condition
Condition
Oral cancer
Classification by specialty
| Oral surgery | Dental medicine | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Effects of allopurinol mouthwash and rebamipide gargle for stomatitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
stomatitis
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
allopurinol
Interventions/Control_2
rebamipide
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
oral cancer patients
Key exclusion criteria
Healthy human
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasunori Sato |
Organization
National Defense Medical College
Division name
Oral and Maxillo Facial Surgery
Zip code
Address
3-2 Namiki, Tokorozawa, Saitama
TEL
04-2995-1925
satosan@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasunori Sato |
Organization
National Defense Medical College
Division name
Oral and Maxillo Facial Surgery
Zip code
Address
3-2 Namiki, Tokorozawa, Saitama
TEL
04-2995-1925
Homepage URL
satosan@ndmc.ac.jp
Sponsor or person
Institute
Oral and Maxillo Facial Surgery, National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
Oral and Maxillo Facial Surgery, National Defense Medical College
Organization
Division
Category of Funding Organization
Other
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
防衛医科大学校病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 13 | 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
| 2011 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 13 | Day |
Last modified on
| 2013 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013750
