UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000010191
Receipt No. R000011934
Scientific Title The examination of the clinical response of celecoxib in Darier's disease and Hailey-Hailey disease
Date of disclosure of the study information 2013/04/01
Last modified on 2016/03/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The examination of the clinical response of celecoxib in Darier's disease and Hailey-Hailey disease
Acronym The examination of the clinical response of celecoxib in Darier's disease and Hailey-Hailey disease
Scientific Title The examination of the clinical response of celecoxib in Darier's disease and Hailey-Hailey disease
Scientific Title:Acronym The examination of the clinical response of celecoxib in Darier's disease and Hailey-Hailey disease
Region
Japan

Condition
Condition Drier's disease Hailey-Hailey disease
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The examination of the clinical response of celecoxib in Darier's disease and Hailey-Hailey disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We evaluate it with clinical symptom degree of improvement
1 erythema area
2 erosion area
3 egree of improvement of a pain and itch using a VAS scale
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 celecoxib
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 A person of Darier disease and Hailey-Hailey disease which was already diagnosed in Juntendo University.
Key exclusion criteria 1 The patients who have an allergy to celecoxib
2 The patients with the aspirin asthma and gastrointestinal ulceration
3 The patients with serious hepatopathy and nephropathy
4 The patients with the heart disease
5 The patients during the pregnancy or breast-feeding
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Takagi
Organization Juntendo university gradurate school of medicine
Division name Department of ermatology
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Juntendo university gradurate school of medicine
Division name Department of ermatology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Juntendo university gradurate school of medicine
Institute
Department

Funding Source
Organization Juntendo university gradurate school of medicine
Organization
Division
Category of Funding Organization Self funding
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
2013 Year 04 Month 01 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 Preinitiation
Date of protocol fixation
2013 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 03 Month 08 Day
Last modified on
2016 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011934

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.