UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011455 |
|---|---|
| Receipt number | R000013298 |
| Scientific Title | The involvement of mesalazine concentration in colonic mucosa of patients with ulcerative colitis under treatment with oral mesalazine |
| Date of disclosure of the study information | 2013/09/01 |
| Last modified on | 2013/08/11 13:58:52 |
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Basic information
Public title
The involvement of mesalazine concentration in colonic mucosa of patients with ulcerative colitis under treatment with oral mesalazine
Acronym
The involvement of mesalazine concentration in colonic mucosa of UC patients
Scientific Title
The involvement of mesalazine concentration in colonic mucosa of patients with ulcerative colitis under treatment with oral mesalazine
Scientific Title:Acronym
The involvement of mesalazine concentration in colonic mucosa of UC patients
Region
| Japan |
Condition
Condition
Ulcerative Colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of concentration measurement of mesalazine in colonic mucosa as a predictive facor for mesalazine treatment in UC patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
concentration measurement of colinic mesalazine
Key secondary outcomes
1:Clinical activity index (partial UC-DAI)
2:Endoscopic findings
3:Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Asacol group
Interventions/Control_2
Pentasa Group
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1:Patients with UC
2:Patients with actice UC (score of UC-DAI:3-8)
3:Patients treated with pentasa (=/<2250mg)
4:An outpatient
Key exclusion criteria
1:UC patients who were treated with pentasa enema or salazosulfapyridine suppository
2:Patients with rectal sparing
3:Patients who have a contraindication against mesalazine
4:Patients with severe renal failure
5:Patients with severe hepatic failure
6:Patients treated with prokinetic agents
7:Concomitant malignancies
8:Patients after gastrectomy
9:Under 20 year-old
10:no agreement for this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Nakase |
Organization
Kyoto University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-4319
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuya Yoshino |
Organization
Kyoto University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-4319
Homepage URL
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology, Kyoto University 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
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
京都大学医学部附属病院、慶応義塾大学病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 11 | Day |
Last modified on
| 2013 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013298
