UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022512 |
|---|---|
| Receipt number | R000025949 |
| Scientific Title | Pharmacokinetics of 5ASA, immunosuppressive agents and biologics with inflammatory bowel disease patients |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2019/12/04 16:40:32 |
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Basic information
Public title
Pharmacokinetics of 5ASA, immunosuppressive agents and biologics with inflammatory bowel disease patients
Acronym
Pharmacokinetics of 5ASA, immunosuppressive agents and biologics with inflammatory bowel disease patients
Scientific Title
Pharmacokinetics of 5ASA, immunosuppressive agents and biologics with inflammatory bowel disease patients
Scientific Title:Acronym
Pharmacokinetics of 5ASA, immunosuppressive agents and biologics with inflammatory bowel disease patients
Region
| Japan |
Condition
Condition
Inflammatory bowel disease
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To ingvestigate the pharmacokinetics of 5ASA, immunosuppressive agents and biologics in IBD patient for optimization of treatments
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the coalition between the pharmacokinetic parameters, drug metabolization factors and clinical outcomes
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
| Maneuver |
Interventions/Control_1
blood test
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Object: the hospitalized patients with moderate or severe IBD.
They should be treated by immunosuppressive agents and agreement are required before the blood test for pharmakokinetics and drug metabolization ability chek.
Key exclusion criteria
Without agreement.
In inapproapiriate situation for several times of blood test.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Hirooka |
Organization
Nagoya University Hospital
Division name
Department of Endoscopy
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya city
TEL
052-744-2172
hirooka@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Watanabe |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya city
TEL
052-744-2144
Homepage URL
osa-wata@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Department of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
NA
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
| 2016 | Year | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 29 | Day |
Last modified on
| 2019 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025949
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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