UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007197 |
|---|---|
| Receipt number | R000008475 |
| Scientific Title | Assessment of adalimumab self injection in Crohn's disease-Pearl survey |
| Date of disclosure of the study information | 2012/02/01 |
| Last modified on | 2012/09/24 14:10:37 |
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Basic information
Public title
Assessment of adalimumab self injection in Crohn's disease-Pearl survey
Acronym
Assessment of adalimumab self injection
Scientific Title
Assessment of adalimumab self injection in Crohn's disease-Pearl survey
Scientific Title:Acronym
Assessment of adalimumab self injection
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal benefit and problems of adalimumab self injection in Crohn's disease by Questionnaire for patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Satisfaction rate of adalimumab self injection.
Key secondary outcomes
Pain of adalimumab self injection.
Adherence of adalimumab self injection.
Anxiety of adalimumab self injection.
Problems of adalimumab self injection.
etc
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Crohn's disease patients who under treatment of adalimumab self injection
Key exclusion criteria
Patients who do not give consent to participate in the survey.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Matsui |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-1-1 Zokumyouin, Chikushino, Fukuoka Pref
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumihito Hirai |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
fuhirai@cis.fukuoka-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Fukuoka University Chikushi Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
福岡大学筑紫病院（福岡）、大阪市立大学（大阪）、兵庫医科大学（兵庫）、九州大学（福岡）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | 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
Completed
Date of protocol fixation
| 2011 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Subject:Crohn's disease patients who under treatment of adalimumab self injection
Target sample size:100
Method:Questionaire for patients
Contents:Assesment of efficacy and problems of adalimumab self injection.
Number of institusion:4 institusions
Management information
Registered date
| 2012 | Year | 02 | Month | 01 | Day |
Last modified on
| 2012 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008475
