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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026175
Receipt No. 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

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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
Email 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/
Email akharada@intmed2.med.kyushu-u.ac.jp

Sponsor
Institute Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030077

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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