UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized clinical trial on the efficacy of 5-fluorouracil(5-FU) ointment on the outer and middle ear cholesteatoma
Title of the study (Brief title)	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	Haruo Takahashi
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Otolaryngology-Head and Neck Surgery
Address	1-7-1 Sakamoto, Nagasaki city, Nagasaki
TEL	0958197350
Email	htak0831@nagasaki-u.ac.jp

Public contact
Name of contact person	Kensuke Hatachi
Organization	Nagasaki University hospital
Division name	Department of Otolaryngology-Head and Neck Surgery
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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 01 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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