UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043333 |
|---|---|
| Receipt number | R000049343 |
| Scientific Title | Clinical Trial Mock Simulation Phase IIa Trial in Luminal Crohn's Disease |
| Date of disclosure of the study information | 2021/02/23 |
| Last modified on | 2021/10/29 16:44:35 |
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Basic information
Public title
Clinical Trial Mock Simulation
Phase IIa Trial in Luminal Crohn's Disease
Acronym
Clinical Trial Mock Simulation
Scientific Title
Clinical Trial Mock Simulation
Phase IIa Trial in Luminal Crohn's Disease
Scientific Title:Acronym
Clinical Trial Mock Simulation
Region
| Japan | Asia(except Japan) | North America |
| Europe |
Condition
Condition
Luminal 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 IIa trial in luminal CD in order to:
-Understand patient and caregiver needs and expectations
-Deliver on patient and caregiver needs in this clinical trial and non-trial activities
-Raise patient satisfaction with 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
A clinical trial mock simulation for a Phase IIa trial in luminal Crohn's Disease
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
-Diagnosis of luminal CD
-Male or female patients
-18+ years of age
Key exclusion criteria
Not applicable
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
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
nobutaka.yagi@boehringer-ingelheim.com
Sponsor or person
Institute
Nippon Boehringer Ingelheim Co., Ltd.
Institute
Department
Personal name
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-Ume da Clinic Ethics Review Committee
Address
Maruit Nishi-Umeda Building 3F, 3-3-45 Umed a, Kita-ku, Osaka-shi, Osaka, Japan
Tel
06-4797-5660
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 | 02 | Month | 23 | 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 | 01 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 02 | Month | 16 | Day |
Last modified on
| 2021 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049343
