UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000025949