UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005443 |
|---|---|
| Receipt number | R000006460 |
| Scientific Title | Investigation of incidence of measles, mumps and rubella in patients with inflammatory bowel disease |
| Date of disclosure of the study information | 2011/04/14 |
| Last modified on | 2013/01/13 18:50:40 |
* 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
Investigation of incidence of measles, mumps and rubella in patients with inflammatory bowel disease
Acronym
Serological test and vaccinations for measles, mumps and rubella in patients with inflammatory bowel disease
Scientific Title
Investigation of incidence of measles, mumps and rubella in patients with inflammatory bowel disease
Scientific Title:Acronym
Serological test and vaccinations for measles, mumps and rubella in patients with inflammatory bowel disease
Region
| Japan |
Condition
Condition
ulcerative colitis, Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Serological test for measles, mumps,rubella, and varicella zoster in patients with inflammatory bowel disease
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Investigation of seronegative rates for measles, mumps, rubella and varicella zoster in IBD patients treated with 5-ASA, 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
| 16 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with diagnosed UC and CD
Age is more than 16
Male and female patients can be entried to this study
Key exclusion criteria
Only UC and CD patients can be included.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Naganuma |
Organization
School of Medicine, Tokyo Medical and Dental University
Division name
Gastroenterology and Hepatology
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
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
TEL
Homepage URL
Sponsor or person
Institute
Gastroenterology and Hepatology
Tokyo Medicaland 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
| 2010 | Year | 11 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | 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
Investigation of corrlation between medications and seronegative rates for each virus.
Management information
Registered date
| 2011 | Year | 04 | Month | 14 | Day |
Last modified on
| 2013 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006460
