UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005445 |
|---|---|
| Receipt number | R000006462 |
| Scientific Title | Investigation of incidence of infections in patients with IBD |
| Date of disclosure of the study information | 2011/04/14 |
| Last modified on | 2011/04/14 21:48:12 |
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Basic information
Public title
Investigation of incidence of infections in patients with IBD
Acronym
Incidnece of influenza infection and other infections inpatients with IBD
Scientific Title
Investigation of incidence of infections in patients with IBD
Scientific Title:Acronym
Incidnece of influenza infection and other infections inpatients with IBD
Region
| Japan |
Condition
Condition
Ulcerative colitis, Crohn's disease, Indeterminate colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the incidence of influenza, urinary tract infections, and opportunistic infections in IBD patients on steroids, immunomodulators and biologics.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the incidence of influenza, urinary tract infections, and opportunistic infections in IBD patients on steroids, immunomodulators and biologics.
Key secondary outcomes
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
outpatients with IBD
Key exclusion criteria
Patients with other disease should be excluded.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Nagnauma |
Organization
School of Medicine, Tokyo Medical and Dental University
Division name
Gastroenterology and Hepatology
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
School of Medicine, Tokyo Medical and Dental University
Division name
Gastroenterology and Hepatology
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Gastroenterology and Hepatology, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
self funding
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
| 2011 | Year | 04 | Month | 14 | 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
| 2009 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 02 | Month | 01 | Day |
Other
Other related information
This study has been finished
Management information
Registered date
| 2011 | Year | 04 | Month | 14 | Day |
Last modified on
| 2011 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006462
