UMIN-CTR Clinical Trial

Basic information
Public title	Utility of Topical Estoriol on the Nasal Mucosa in a Patient with Osler Disease
Acronym	Utility of Topical Estoriol on the Nasal Mucoza in Patient witn Osler's disease
Scientific Title	Utility of Topical Estoriol on the Nasal Mucosa in a Patient with Osler Disease
Scientific Title:Acronym	Utility of Topical Estoriol on the Nasal Mucoza in Patient witn Osler's disease
Region	Japan

Condition
Condition	Osler's disease(Heredity Hemorragic telangiectasia)
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this sutdy is that we test the utility of Entoriol ointoment for Osler's disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Assesment of symptom after as below for the Osler's disesase. Osler's disease patients use Estoriol ointoment. Assesment:medical examination at the department of otorhinolaryngology with a disease questionnarie.
Key secondary outcomes	After 3 motnths from treatment,we check serum estriol. Assesment:serum estriol

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	estoriol ointment
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	nasal bleeding
Key exclusion criteria	Patients judged inappropriate for this study
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Ken-ichi Middle name Last name Nibu
Organization	kobe Universuty Graduate Shool of Medicine
Division name	Department of otorhinolaryngology head and Neck Surgery
Zip code	650-0017
Address	7-5-1,Kusunoki-cho,Chuo-ku,Kobe,Hyogo,650-0017,Japan
TEL	81-78-382-5111
Email	nibu@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Ken-ichi Middle name Last name Nibu
Organization	Kobe Universuty Graduate Shool of Medicine
Division name	Department of otorhinolaryngology head and Neck Surgery
Zip code	650-0017
Address	7-5-1,Kusunoki-cho,Chuo-ku,Kobe,Hyogo,650-0017,Japan
TEL	81-78-382-5111
Homepage URL	http://www.kobe-u.ac.jp/chiken/OOchiken_top.hym
Email	nibu@med.kobe-u.ac.jp

Sponsor
Institute	Kobe Universuty Graduate Shool of Medicine
Institute
Department

Funding Source
Organization	Kobe Universuty Graduate Shool of Medicine
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	Kobe Univ. Hosp. Clin Transl Res Center
Address	7-5-2, Kusunoki-cho, Kobe City, Hyogo, Japan
Tel	078-482-6669
Email	chiken@med.kobe-u.ac.jp

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	2015 Year 06 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	No longer recruiting
Date of protocol fixation	2015 Year 01 Month 10 Day
Date of IRB	2015 Year 01 Month 10 Day
Anticipated trial start date	2015 Year 02 Month 01 Day
Last follow-up date	2021 Year 01 Month 31 Day
Date of closure to data entry	2021 Year 01 Month 31 Day
Date trial data considered complete	2021 Year 01 Month 31 Day
Date analysis concluded	2021 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date	2015 Year 06 Month 05 Day
Last modified on	2020 Year 06 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018109

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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