UMIN-CTR Clinical Trial

Basic information
Public title	Clinical Trial Mock Simulation Research Plan Phase IIb Trial in Fistulising Crohn's Disease
Acronym	Clinical Trial Mock Simulation Research Plan Phase IIb Trial in Fistulising Crohn's Disease
Scientific Title	Clinical Trial Mock Simulation Research Plan Phase IIb Trial in Fistulising Crohn's Disease
Scientific Title:Acronym	Clinical Trial Mock Simulation Research Plan Phase IIb Trial in Fistulising Crohn's Disease
Region	Japan Asia(except Japan) Europe

Condition
Condition	Fistulising Crohn's Disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this clinical trial mock simulation is to gather patient and healthcare provider (HCP) feedback about the design of a Phase IIb trial in fistulising CD in order to: Understand patient and caregiver needs and expectations Deliver on patient and caregiver needs in BI trial and non-trial activities Raise patient satisfaction with BI trials, medicines and support services Enhance disease awareness and patient information Support patient access to care and healthcare services Understand and support the objectives of patient organisations
Basic objectives2	Others
Basic objectives -Others	Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Experience with conducting clinical trials, e.g. investigator or study coordinator
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	PATIENTS Diagnosis of fistulising CD Male or female patients 18+ years old HEALTH CAREPROFESSIONAL Experience with conducting clinical trials, e.g. investigator or study coordinator From the same country as the patient with whom they will participate in the virtual trial visit simulation
Key exclusion criteria	None
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Nobutaka Middle name Last name Yagi
Organization	Nippon Boehringer Ingelheim Co., Ltd.
Division name	Medicine Division
Zip code	141-6017
Address	2-1-1 Osaki, Shinagawa-ku, Tokyo, Japan
TEL	03-6417-2043
Email	nobutaka.yagi@boehringer-ingelheim.com

Public contact
Name of contact person	1st name Nobutaka Middle name Last name Yagi
Organization	Nippon Boehringer Ingelheim Co., Ltd.
Division name	Medicine Division
Zip code	141-6017
Address	2-1-1 Osaki, Shinagawa-ku, Tokyo, Japan
TEL	03-6417-2043
Homepage URL
Email	nobutaka.yagi@boehringer-ingelheim.com

Sponsor
Institute	Nippon Boehringer Ingelheim Co., Ltd.
Institute
Department

Funding Source
Organization	Nippon Boehringer Ingelheim Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Medical Corporation Kyoso-kai AMC Nishi-Umeda Clinic Ethics Review Committee
Address	Maruit Nishi-Umeda Building 3F, 3-3-45 Umeda, Kita-ku, Osaka-shi, Osaka, Japan
Tel	06-4797-5660
Email	morikawa@amc-clinic.jp

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	2021 Year 06 Month 04 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	3
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	2020 Year 12 Month 09 Day
Date of IRB	2021 Year 05 Month 21 Day
Anticipated trial start date	2021 Year 05 Month 24 Day
Last follow-up date	2021 Year 11 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Non-interventional study

Management information
Registered date	2021 Year 06 Month 04 Day
Last modified on	2022 Year 03 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050525