UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011358 |
|---|---|
| Receipt number | R000013274 |
| Scientific Title | Cost-effectiveness of anti-TNFalfa treatment for IBD |
| Date of disclosure of the study information | 2013/12/01 |
| Last modified on | 2014/09/03 19:52:37 |
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Basic information
Public title
Cost-effectiveness of anti-TNFalfa treatment for IBD
Acronym
Cost-effectiveness of anti-TNFalfa treatment for IBD
Scientific Title
Cost-effectiveness of anti-TNFalfa treatment for IBD
Scientific Title:Acronym
Cost-effectiveness of anti-TNFalfa treatment for IBD
Region
| Japan |
Condition
Condition
Inflammatory bowel disease
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify cost-effectiveness of anti-TNFalfa treatment in IBD patients
Basic objectives2
Others
Basic objectives -Others
Cost-effectiveness
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To determine the incremental cost-effectiveness ratio of anti-TNFalfa treatment in IBD patients
Key secondary outcomes
To determine the relationship between disease activity and QOL in IBD patients
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with inflammatory bowel disease
Key exclusion criteria
severe heart failure
severe kidny disease
severe infection
severe diabetes
severe hypovolemic or nutrirional disorder
other severe complications
under 16-years-old
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Kogo |
Organization
Asahikawa Medical University
Division name
Department of Medicine
Zip code
Address
2-1, Midorigaoka-higasi, Asahikawa, Hokkaido, 078-8510, Japan
TEL
0166-68-2462
ta1983@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Dokoshi |
Organization
Asahikawa Medical University
Division name
Department of Medicine
Zip code
Address
asahikawa city midorigaoka higashi 2-1-1-1
TEL
0166-68-2462
Homepage URL
ta1983@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | 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
reserching
Management information
Registered date
| 2013 | Year | 08 | Month | 02 | Day |
Last modified on
| 2014 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013274
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
