UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026175 |
|---|---|
| Receipt number | R000030077 |
| Scientific Title | Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis |
| Date of disclosure of the study information | 2017/03/01 |
| Last modified on | 2019/03/12 13:37:15 |
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Basic information
Public title
Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis
Acronym
Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis
Scientific Title
Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis
Scientific Title:Acronym
Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, patients with ulcerative colitis in a fixed amount of time-dependent mesalazine granule preparation or orally administered pH-dependent mesalazine tablets underwent rectal examination by clinical findings, specimen examination, image examination, and lower endoscopic examination of periodic examination , Secondary utilization of biopsy tissue in the cecum to measure the concentration of 5-ASA and acetyl 5-ASA in the colonic mucosa and to compare the usefulness of time-dependent mesalazine granule preparation and pH dependent mesalazine tablet.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in the concentrations of 5-ASA and acetyl 5-ASA in rectal, cecal biopsy tissue, remission induction rate / maintenance rate (Mayo 1 or less)
Key secondary outcomes
Drug efficacy rate (improvement of CAI by 30% or more), remission maintenance rate and duration, side effect occurrence rate, endoscopic findings, CRP, change amount of calprotectin in the stool
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Time dependent mesalazine granule formulation After bottom of the 8th week from the start of administration, the lower endoscopy was performed and the mucous membrane was collected from the cecum and rectum by biopsy and the concentration of 5-ASA and acetyl 5-ASA in the mucosa was measured in the mucosa .
Interventions/Control_2
PH dependent mesalazine granule preparation Lower endoscopy was performed 8 weeks after the start of administration, mucosa was collected from the cecum and rectum by biopsy, and the concentration of 5-ASA and acetyl 5-ASA in the mucosa was measured at the drug part .
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with remission, mild or moderate ulcerative colitis (endoscopic Mayo score 2 or less, or less severe classification by Suzuki team of the Ministry of Health, Labor and Welfare)
2) Patients who aged 20 years or older at the time of acquiring consent.
3) Patients who have not changed the contents of medication to the original disease within the last 8 weeks of participation in this study.
4) Time-dependent mesalazine granule preparation 2.0 - 4.0 mg / day or pH dependent mesalazine tablet 2.4 - 4.8 mg / day Patients who received written informed consent.
Key exclusion criteria
1) People with severe or fulminant ulcerative colitis. (Mayo score 2 or less, or less severe classification by Suzuki team of Ministry of Health, Labor and Welfare)
2) Patients undergoing total colon resection, subtotal puncture surgery etc.
3) Patients with liver dysfunction and renal dysfunction.
4) Patients undergoing antithrombotic therapy or anticoagulant therapy and patients with thrombocytopenia.
5) Pregnant women or patients who may be pregnant, breast-feeding patients.
6) Patients who are merging psychosis or psychiatric symptoms and are considered difficult to participate in the study.
7) Other patients who decided that the doctor in charge is inappropriate, such as a decline in compliance.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tnakanari Kitazono |
Organization
Kyushu University
Division name
Department of Medicine and Clinical Science, Graduate School of Medical Sciences
Zip code
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5261
akharada@intmed2.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Harada |
Organization
Kyushu University
Division name
Department of Medicine and Clinical Science, Graduate School of Medical Sciences
Zip code
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5261
Homepage URL
http://www.gut.med.kyushu-u.ac.jp/
akharada@intmed2.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Kyushu University
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
Address
Tel
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
九州大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.gut.med.kyushu-u.ac.jp/
Publication of results
Unpublished
Result
URL related to results and publications
http://www.gut.med.kyushu-u.ac.jp/
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
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 08 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 08 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 16 | Day |
Last modified on
| 2019 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030077
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