UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022954
Receipt No. R000026384
Scientific Title A study related to usability of Mesalazine Controlled-Release Tablets and Granules.
Date of disclosure of the study information 2016/07/05
Last modified on 2018/07/16

* 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 A study related to usability of Mesalazine Controlled-Release Tablets and Granules.
Acronym A study related to usability of Mesalazine Controlled-Release Tablets and Granules.
Scientific Title A study related to usability of Mesalazine Controlled-Release Tablets and Granules.
Scientific Title:Acronym A study related to usability of Mesalazine Controlled-Release Tablets and Granules.
Region
Japan

Condition
Condition ulcerative colitis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1. To compare usability of Mesalazine Controlled-Release Tablets and Granules
2. To evaluate the impact of the usability on adherence, efficacy, and safety
Basic objectives2 Others
Basic objectives -Others usability
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Differences in usability between Mesalazine Controlled-Release Tablets and Granules(by questionnaire)
Key secondary outcomes adherence(by questionnaire)
changes in subjective symptoms,concomitant medications, Lichtiger Score, Mayo Score
occurence of side effect
(during the period of taking tablets or granules)

Base
Study type Interventional

Study design
Basic design Cross-over
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 Patients take Mesalazine Controlled-release tablets at first, 3-12 weeks, then take granules, 3-12 weeks
Interventions/Control_2 Patients take Mesalazine Controlled-release granules at first, 3-12 weeks, then take tablets, 3-12 weeks
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
0 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria 1.patients who are considered to be appropriate to take mesalazine controlled-release tablets and granules
2.patients who considered to be able to evaluate usability of medication
3.patients from whom written informed consent was obtained
Key exclusion criteria Patients who do not meet the above criteria
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taku Kobayashi
Organization Kitasato University Kitasato Institute Hospital
Division name Kitasato University Kitasato Institute Hospital
Zip code
Address 5-9-1 Shirokane, Minato-ku, Tokyo
TEL 03-3444-6161
Email kobataku@insti.kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiji Yagisawa
Organization Kitasato University Kitasato Institute Hospital
Division name Kitasato University Kitasato Institute Hospital
Zip code
Address 5-9-1 Shirokane, Minato-ku, Tokyo
TEL 03-3444-6161
Homepage URL
Email k-yagi@insti.kitasato-u.ac.jp

Sponsor
Institute Kitasato University Kitasato Institute Hospital
Institute
Department

Funding Source
Organization Kitasato University Kitasato Institute 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
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

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 05 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 Open public recruiting
Date of protocol fixation
2016 Year 01 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 06 Month 30 Day
Last modified on
2018 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026384

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.