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
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
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
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
