UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032775
Receipt number R000037321
Scientific Title An observational study on interaction between 5ASA and thiopurine in ulcerative colitis
Date of disclosure of the study information 2018/05/30
Last modified on 2021/12/02 13:34:07

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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 or person

Institute

Kitasato University Kitasato Institute Hospital.

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037321


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name