UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010191 |
|---|---|
| Receipt number | 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 14:57:24 |
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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
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
Sponsor or person
Institute
Juntendo university gradurate school of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011934
