UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024217 |
|---|---|
| Receipt number | R000027876 |
| Scientific Title | Randomized clinical trial on the efficacy of 5-fluorouracil(5-FU) ointment on the outer and middle ear cholesteatoma |
| Date of disclosure of the study information | 2016/09/30 |
| Last modified on | 2016/09/29 10:47:42 |
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Basic information
Public title
Randomized clinical trial on the efficacy of 5-fluorouracil(5-FU) ointment on the outer and middle ear cholesteatoma
Acronym
Randomized clinical trial on the efficacy of 5-fluorouracil(5-FU) ointment on the outer and middle ear cholesteatoma
Scientific Title
Randomized clinical trial on the efficacy of 5-fluorouracil(5-FU) ointment on the outer and middle ear cholesteatoma
Scientific Title:Acronym
Randomized clinical trial on the efficacy of 5-fluorouracil(5-FU) ointment on the outer and middle ear cholesteatoma
Region
| Japan |
Condition
Condition
outer ear cholesteatoma, middle ear cholesteatoma
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether there is a difference in the therapeutic efficacy on outer ear and middle ear cholesteatoma between 5-FU ointment and the placebo medicine (hydrophilic cream) by randomized double-blind trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference of the area (mm2) of the cholesteatoma in the slice that the cholesteatoma shadow was depicted at a maximum area before treatment in temporal bone axial CT
Key secondary outcomes
Size and/or visibility of cholesteatoma mass through transmeatal endoscopy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
outer ear cholesteatoma
5-FU : 8 ears
Placebo(hydrophilic cream) : 8 ears
Dose:The 5-FU ointment or placebo medicine of the piece of rice size(200mg) is applied to the cholesteatoma with a cotton swab three times every 2-3 weeks
Period:18-19 weeks from agreement acquisition
Interventions/Control_2
middle ear cholesteatoma
5-FU : 16 ears
Placebo(hydrophilic cream) : 16 ears
Dose:The 5-FU ointment or placebo medicine of the piece of rice size(200mg) is applied to the cholesteatoma with a cotton swab three times every 2-3 weeks
Period:18-19 weeks from agreement acquisition
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.outer ear cholesteatoma or middle ear cholesteatoma equivalent to a mild to moderate leision
2.patient 20 years or older at the time of the agreement acquisition
3.outpatient
4.The patients from whom informed consent from their free will was obtained after a sufficient explanation.
Key exclusion criteria
1.advanced cholesteatoma
2.middle ear cholesteatoma having eardrum perforation or an inner ear fistula
3.patients having a history of the drug allergies
4.pregnant patient and those who have possibility of pregnancy, or breast-feeding patient
5.the patient whom a principal investigator judged to be inappropriate as a study subject
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruo Takahashi |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Otolaryngology-Head and Neck Surgery
Zip code
Address
1-7-1 Sakamoto, Nagasaki city, Nagasaki
TEL
0958197350
htak0831@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kensuke Hatachi |
Organization
Nagasaki University hospital
Division name
Department of Otolaryngology-Head and Neck Surgery
Zip code
Address
1-7-1 Sakamoto, Nagasaki city, Nagasaki
TEL
0958197350
Homepage URL
kensuke-hatachi@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Graduate School of Biomedical Sciences
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
| 2016 | 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
Date of protocol fixation
| 2016 | Year | 01 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 24 | 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
| 2016 | Year | 09 | Month | 29 | Day |
Last modified on
| 2016 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027876
