UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053499 |
|---|---|
| Receipt number | R000061052 |
| Scientific Title | Unmet Needs Questionnaire Survey in Adult Patients with SBS |
| Date of disclosure of the study information | 2024/02/01 |
| Last modified on | 2024/12/23 12:16:49 |
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Basic information
Public title
Unmet Needs Questionnaire Survey in Adult Patients with SBS
Acronym
Unmet Needs Questionnaire Survey in Adult Patients with SBS
Scientific Title
Unmet Needs Questionnaire Survey in Adult Patients with SBS
Scientific Title:Acronym
Unmet Needs Questionnaire Survey in Adult Patients with SBS
Region
| Japan |
Condition
Condition
short bowel syndrome
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the specific concerns of SBS patients and what healthcare professionals should consider when interviewing patients.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Contribution of unmet needs (treatment-related) to SBS-QoL
Contribution of unmet needs (daily life related) to SBS-QoL
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
Individuals aged 18 years or older.
Individuals who self-report to have SBS meeting either 1 or 2, and 3 of the followings
1.Who have undergone small bowel resection
2.Who have small intestinal stoma for decompression
3.Who have received parenteral nutrition continuously to compensate for decreased intestinal function
Key exclusion criteria
Individuals who cannot read and understand Japanese
Target sample size
100
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 | Nozomi |
| Middle name | |
| Last name | Kamijo |
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
03-3278-2111
Homepage URL
nozomi.kamijo@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
Name of secondary funder(s)
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
| 2024 | Year | 02 | Month | 01 | 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 | 12 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2024 | Year | 01 | Month | 31 | Day |
Last modified on
| 2024 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061052
