UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036049 |
|---|---|
| Receipt number | R000041065 |
| Scientific Title | A study on medication compliance of Pentasa granules in patients with inflammatory bowel disease |
| Date of disclosure of the study information | 2019/03/01 |
| Last modified on | 2019/02/28 19:03:41 |
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Basic information
Public title
A study on medication compliance of Pentasa granules in patients with inflammatory bowel disease
Acronym
A study on medication compliance of Pentasa granules
Scientific Title
A study on medication compliance of Pentasa granules in patients with inflammatory bowel disease
Scientific Title:Acronym
A study on medication compliance of Pentasa granules
Region
| Japan |
Condition
Condition
inflammatory bowel disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate medication compliance at switching to Pentasa granules from Pentas tablets in patients with inflammatory bowel disease
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of medication compliance at switching to Pentasa granules from Pentas tablets in patients with inflammatory bowel disease
Key secondary outcomes
The aim of this study is to evaluate safety and disease activity at switching to Pentasa granules from Pentas tablets in patients with inflammatory bowel disease
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pentasa tablets (1-2 months)
Pentasa granules (1-2 months)
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
Inflammatory bowel disease patients who are medicated by Pentasa tablets
Key exclusion criteria
Physicians exclude the patients who is inappropriate for registration to this study due to high disease activity
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunji Ishihara |
Organization
Shimane University Faculty of Medicine
Division name
Internal Medicine II
Zip code
Address
Enya-cho 89-1, Izumo, ShImane
TEL
0853-20-2190
si360405@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunji Ishihara |
Organization
Shimane University Faculty of Medicine
Division name
Internal Medicine II
Zip code
Address
Enya-cho 89-1, Izumo, ShImane
TEL
0853-20-2190
Homepage URL
si360405@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Faculty of Medicine
Internal Medicine II
Institute
Department
Personal name
Funding Source
Organization
Shimane University Faculty of Medicine
Internal Medicine II
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | 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
Suspended
Date of protocol fixation
| 2017 | Year | 06 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | 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
| 2019 | Year | 02 | Month | 28 | Day |
Last modified on
| 2019 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041065
