UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on medication compliance of Pentasa granules in patients with inflammatory bowel disease
Title of the study (Brief title)	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	Shunji Ishihara
Organization	Shimane University Faculty of Medicine
Division name	Internal Medicine II
Address	Enya-cho 89-1, Izumo, ShImane
TEL	0853-20-2190
Email	si360405@med.shimane-u.ac.jp

Public contact
Name of contact person	Shunji Ishihara
Organization	Shimane University Faculty of Medicine
Division name	Internal Medicine II
Address	Enya-cho 89-1, Izumo, ShImane
TEL	0853-20-2190
Homepage URL
Email	si360405@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University Faculty of Medicine Internal Medicine II
Institute
Department

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)

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

Progress
Recruitment status	Suspended
Date of protocol fixation	2017 Year 06 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041065