UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010127
Receipt No. R000011862
Scientific Title Comparative study for mucosal concentration of 5-ASA by once-daily vs divided dosing of oral mesalazine in quiescent ulcerative colitis
Date of disclosure of the study information 2013/04/01
Last modified on 2016/06/02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Comparative study for mucosal concentration of 5-ASA by once-daily vs divided dosing of oral mesalazine in quiescent ulcerative colitis
Acronym Mucosal concentration of 5-ASA by once-daily vs conventional dosing
Scientific Title Comparative study for mucosal concentration of 5-ASA by once-daily vs divided dosing of oral mesalazine in quiescent ulcerative colitis
Scientific Title:Acronym Mucosal concentration of 5-ASA by once-daily vs conventional dosing
Region
Japan

Condition
Condition ulcerative colitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the mucosal concentration of 5-ASA by once-daily vs divided dosing in quiescent ulcerative colitis patients
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Mucosal concentration of 5-ASA in the Rectum
Key secondary outcomes Mucosal concentration of Ac-5-ASA in the rectum

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Eligible patients will be treated with 3g of oral mesalazine once daily for at least two weeks
Interventions/Control_2 Eligible patients will be treated with 3g of oral mesalazine twice daily for at least two weeks
Interventions/Control_3 Eligible patients will be treated with 3g of oral mesalazine three times daily for at least two weeks
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 1) Outpatients
2) Adult patients who have been in remission by the treatment with oral mesalazine
3) Patients who able provided written informed consent
Key exclusion criteria 1) Patients with severe active or fulminant ulcerative colitis
2) Patients who received total or subtotal colectomy
3) Patients with malignancy
4) Patients who are pregnant or have the possibility of pregnancy
5) Patients whom investigators and subinvestigators considered to be inappropriate to participate in this study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Minoru Matsuura
Organization Kyoto University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan
TEL 075-751-4319
Email minomats@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Minoru Matsuura
Organization Kyoto University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan
TEL 075-751-4319
Homepage URL
Email minomats@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Kyoto University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization JAPAN

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 京都大学医学部附属病院(京都府)

Other administrative information
Date of disclosure of the study information
2013 Year 04 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 Completed
Date of protocol fixation
2011 Year 11 Month 17 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 24 Day
Last follow-up date
2016 Year 06 Month 30 Day
Date of closure to data entry
2016 Year 06 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 02 Month 26 Day
Last modified on
2016 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011862

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.