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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000024217
Receipt No. 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

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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
Email 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
Email kensuke-hatachi@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027876

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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