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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000022512
Receipt No. 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

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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
Email 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
Email osa-wata@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Department of Gastroenterology and Hepatology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025949

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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