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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031241
Receipt No. R000035669
Scientific Title Clinical study of 5-ASA concentration in colonic mucosa for patients with ulcerative colitis
Date of disclosure of the study information 2018/02/19
Last modified on 2019/03/27

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Basic information
Public title Clinical study of 5-ASA concentration in colonic mucosa for patients with ulcerative colitis
Acronym Clinical study of 5-ASA concentration in colonic mucosa for patients with ulcerative colitis
Scientific Title Clinical study of 5-ASA concentration in colonic mucosa for patients with ulcerative colitis
Scientific Title:Acronym Clinical study of 5-ASA concentration in colonic mucosa for patients with ulcerative colitis
Region
Japan

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

Objectives
Narrative objectives1 This study investigate relationship between colonic mucosa concentration of 5-ASA preparation and endoscopic disease activity level.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between 5-ASA concentration in colonic mucosa and colonic endoscopic activity
Key secondary outcomes Correlation between 5-ASA concentration in colonic mucosa and clinical symptoms (Partial UCDAI, DAI, Lichtiger index)

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Men and women aged 20 years and over.
Patients diagnosed with mild or moderate ulcerative colitis.
Patients scheduled to undergo colonoscopy.
Patients taking at least 5-ASA preparation at the same dose for 8 weeks or more at the time of endoscopy
Patients who can obtain consent to participate in the examination by document.
Patients who the doctor admitted to participate in this study
Key exclusion criteria Patients who have been 6 weeks or more past relapse diagnosis.
Patients with poor medication adherence for 5-ASA drugs
Cases using 5-ASA topical therapy (suppository, enema preparation) within 1 week of endoscopy
Patient who used steroid formulation (suppository, enema, oral steroid formulation, steroid injectable formulation) or biologic formulation within 2 weeks of endoscopic enrollment.
Patients with Crohn's disease or peptic ulcer
Patients with history of colorectal surgery
Patients with severe renal and liver impairment
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Makoto
Middle name
Last name Naganuma
Organization Keio University
Division name Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code 160-8582
Address 35 Shinano-machi, Shinjyu-ku , Tokyo
TEL 03-3353-1211
Email maknaganuma@gmail.com

Public contact
Name of contact person
1st name Makoto
Middle name
Last name Naganuma
Organization Keio University
Division name Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code 1608582
Address 35 Shinano-machi, Shinjyu-ku , Tokyo
TEL 03-3353-1211
Homepage URL
Email nagamakoto@z7.keio.jp

Sponsor
Institute Keio University Division of Gastroenterology and Hepatology, Department of Internal Medicine
Institute
Department

Funding Source
Organization MOCHIDA PHARMACEUTICAL CO.,LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Keio University School of Medicine Ethics Committee
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
Tel 03-3353-1211
Email med-rinri-jimu@adst.keio.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 02 Month 19 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
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
2018 Year 02 Month 09 Day
Date of IRB
2018 Year 03 Month 02 Day
Anticipated trial start date
2018 Year 03 Month 02 Day
Last follow-up date
2019 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2018 Year 02 Month 10 Day
Last modified on
2019 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035669

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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