UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052594 |
|---|---|
| Receipt number | R000060018 |
| Scientific Title | Expert Opinion on the Proper Use of Teduglutide as Treatment for Short Bowel Syndrome in Adult Patients |
| Date of disclosure of the study information | 2023/10/24 |
| Last modified on | 2024/07/10 15:45:30 |
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Basic information
Public title
Expert Opinion on the Proper Use of Teduglutide as Treatment for Short Bowel Syndrome in Adult Patients
Acronym
Expert Opinion on the Proper Use of Teduglutide as Treatment for Short Bowel Syndrome in Adult Patients
Scientific Title
Expert Opinion on the Proper Use of Teduglutide as Treatment for Short Bowel Syndrome in Adult Patients
Scientific Title:Acronym
Expert Opinion on the Proper Use of Teduglutide as Treatment for Short Bowel Syndrome in Adult Patients
Region
| Japan |
Condition
Condition
short bowel syndrome
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To summarize expert opinions by Short Bowel Syndrome (SBS) experts on the treatment of Teduglutide (TED) using surveys in order to promote the proper use of TEDs for adults
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
An expert opinion on appropriate treatment of adult SBS with TED
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Panelist should have at least 6 months of continuous experience in managing adult SBS patients in the clinical trial or in their routine clinical practice
2. Panelist should belong to a scientific society/conference related to SBS and have the following responsibilities: Professor, associate professor, lecturer, assistance professor, hospital director/ vice director, head/ vice head of department, head of medical office, or person with equivalent responsibility.
3. Panelist should have authored Japanese or International publication/s related to intestinal failure and/or SBS, or made oral/poster
presentation in an SBS-related conference.
4. Panelist should have practical experience using TED, either through participation in the clinical trial or in
their routine clinical practice
* Participants who meet the selection criteria will be selected as panelists.
Key exclusion criteria
Not applicable
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Anna |
| Middle name | Lissa |
| Last name | Hamada |
Organization
Takeda Pharmaceutical Company Limited
Division name
Japan Medical Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo, Japan
TEL
03-3242-1256
anna_lissa.hamada@takeda.com
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Osada |
Organization
Takeda Pharmaceutical Company Limited
Division name
Japan Medical Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo, Japan
TEL
03-3242-1256
Homepage URL
yu.osada@takeda.com
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Not applicable
Name of secondary funder(s)
Not applicable
IRB Contact (For public release)
Organization
Research Institute of Healthcare Data Science
Address
Sumitomo Shiba-Daimon Building 12F, 2-5-5 Shiba-Daimon, Minato-ku, Tokyo
Tel
03-5733-5010
rihds@jmdc.co.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
| 2023 | Year | 10 | Month | 24 | 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
Completed
Date of protocol fixation
| 2023 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 12 | Day |
Date of closure to data entry
| 2024 | Year | 02 | Month | 12 | Day |
Date trial data considered complete
| 2024 | Year | 02 | Month | 14 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 25 | Day |
Other
Other related information
Not applicable
Management information
Registered date
| 2023 | Year | 10 | Month | 24 | Day |
Last modified on
| 2024 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060018
