UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031241 |
|---|---|
| Receipt number | 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 18:47:33 |
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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
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
nagamakoto@z7.keio.jp
Sponsor or person
Institute
Keio University Division of Gastroenterology and Hepatology, Department of Internal Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035669
