UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015816 |
|---|---|
| Receipt number | R000018402 |
| Scientific Title | The efficiency and safety of indomethacin spray for the pain of oral mucositis in patients receiving chemotherapy. |
| Date of disclosure of the study information | 2014/12/05 |
| Last modified on | 2018/09/04 20:28:51 |
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Basic information
Public title
The efficiency and safety of indomethacin spray for the pain of oral mucositis in patients receiving chemotherapy.
Acronym
The efficiency of indomethacin spray for the pain of oral mucositis in patients receiving chemotherapy.
Scientific Title
The efficiency and safety of indomethacin spray for the pain of oral mucositis in patients receiving chemotherapy.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hironobu Hata |
Organization
Hokkkaido cancer center
Division name
Department of dental surgery
Zip code
Address
Sapporo city Shiroishi-Ku Kikusui4-2 3-54
TEL
011-811-9111
hatahiro@sap-cc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hironobu Hata |
Organization
Hokkkaido cancer center
Division name
Department of dental surgery
Zip code
Address
Sapporo city Shiroishi-Ku Kikusui4-2 3-54
TEL
011-811-9111
Homepage URL
hatahiro@sap-cc.go.jp
Sponsor or person
Institute
Hokkkaido cancer center
Institute
Department
Personal name
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)
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 | 12 | Month | 05 | 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 | 11 | Month | 01 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018402
