UMIN-CTR Clinical Trial

Basic information
Public title	An observational study on interaction between 5ASA and thiopurine in ulcerative colitis
Acronym	An observational study on interaction between 5ASA and thiopurine in ulcerative colitis
Scientific Title	An observational study on interaction between 5ASA and thiopurine in ulcerative colitis
Scientific Title:Acronym	An observational study on interaction between 5ASA and thiopurine in ulcerative colitis
Region	Japan

Condition
Condition	Ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this multicenter observational Study, we examine the effect on 6-TGN concentration in blood by changing the type of mesalazine in UC patient who used both mesalazine and thiopurine. And we also verify clinical efficacy and safety.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in blood 6-TGN concentration before and after changing the type of mesalazine
Key secondary outcomes	Clinical efficacy and safety by changing the type of mesalazine

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who diagnosed UC by Ministry of Health, Labor and Welfare Diagnostic criteria of research group on intractable inflammatory bowel disorder (revised version of 2016) Patients who obtained informed consent of this clinical study Patients 18 years of age or older Patients who use both mesalazine and thiopurine Patients who use thiopurine for 8 weeks or more, and have continued for the same amount for 4 weeks or more Patients who have continued the same amount of mesalazine for 4 weeks or more Patients who switch mesalazine formulations to other mesalazine drugs
Key exclusion criteria	Patients after total colonectomy Patients who are concurrently using uric acid synthesis inhibitors
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Hiromu Middle name Last name Morikubo
Organization	Kitasato University Kitasato Institute Hospital
Division name	Center for Advanced IBD Research and Treatment
Zip code	108-8642
Address	5-9-1, Shirokane, Minato-ku, Tokyo, Japan
TEL	03-3444-6161
Email	tomato0112@gmail.com

Public contact
Name of contact person	1st name Hiromu Middle name Last name Morikubo
Organization	Kitasato University Kitasato Institute Hospital
Division name	Center for Advanced IBD Research and Treatment
Zip code	108-8642
Address	5-9-1, Shirokane, Minato-ku, Tokyo, Japan
TEL	03-3444-6161
Homepage URL
Email	tomato0112@gmail.com

Sponsor
Institute	Kitasato University Kitasato Institute Hospital.
Institute
Department

Funding Source
Organization	Kitasato University Kitasato Institute Hospital.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kitasato University Kitasato Institute Hospital Research Department Research Ethics Committee Secretariat
Address	5-9-1, Shirokane, Minato-ku, Tokyo, Japan
Tel	03-3444-6161
Email	kenkyu@insti.kitasato-u.ac.jp

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	2018 Year 05 Month 30 Day

Related information
URL releasing protocol	https://onlinelibrary.wiley.com/doi/abs/10.1111/jgh.15411?af=R
Publication of results	Unpublished

Result
URL related to results and publications	https://onlinelibrary.wiley.com/doi/abs/10.1111/jgh.15411?af=R
Number of participants that the trial has enrolled	50
Results	Results Plasma 5-ASA and N-Ac-5-ASA levels were significantly higher in patients receiving time-dependent mesalazine (n = 12) compared with pH-dependent mesalazine (n = 12) and MMX (n = 15), accompanied by greater TPMT inhibition. Prospective switching from time-dependent mesalazine to MMX decreased 6-TGN levels, increased those of 6-MMP, and increased 6-MMP/6-TGN ratios. Furthermore, this resulted in significantly more relapses than switching from pH-dependent mesalazine to MMX.
Results date posted	2021 Year 12 Month 02 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Thiopurines are often used in combination with mesalazine for the treatment of ulcerative colitis (UC). Mesalazine formulations are delivered to the digestive tract by various delivery systems and absorbed as 5-aminosalicylic acid (5-ASA). 5-ASA is known to inhibit thiopurine S-methyltransferase (TPMT) activity and to affect thiopurine metabolism. There have been no studies comparing TPMT inhibition by multimatrix mesalazine (MMX) with other formulations.
Participant flow	We investigated the difference in TPMT inhibition by different mesalazine formulations and prospectively confirmed the clinical relevance.
Adverse events	None
Outcome measures	Changes in the concentration of 6TGN before and after the change of 5-ASA
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 11 Month 17 Day
Date of IRB	2017 Year 11 Month 17 Day
Anticipated trial start date	2017 Year 11 Month 27 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry	2020 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information	Primary outcomes: Changes in blood 6-TGN concentration before and after changing the type of mesalazine Secondary outcomes: Clinical efficacy and safety by changing the type of mesalazine

Management information
Registered date	2018 Year 05 Month 30 Day
Last modified on	2021 Year 12 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037321