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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000044428
Receipt No. R000050525
Scientific Title Clinical Trial Mock Simulation Research Plan Phase IIb Trial in Fistulising Crohn's Disease
Date of disclosure of the study information 2021/06/04
Last modified on 2021/06/04

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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 No longer recruiting
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
2022 Year 05 Month 23 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
2021 Year 06 Month 04 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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