UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060805 |
|---|---|
| Receipt number | R000069565 |
| Scientific Title | Psychometric Validation of the Japanese Version of the Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) |
| Date of disclosure of the study information | 2026/03/02 |
| Last modified on | 2026/03/04 20:05:31 |
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Basic information
Public title
Validation of the Japanese Version of the Pancreatic Exocrine Insufficiency Questionnaire
Acronym
Validation of the Japanese Version of the Pancreatic Exocrine Insufficiency Questionnaire
Scientific Title
Psychometric Validation of the Japanese Version of the Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q)
Scientific Title:Acronym
Psychometric Validation of the Japanese Version of the Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q)
Region
| Japan |
Condition
Condition
Pancreatic exocrine insufficiency
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the reliability, validity, and discriminative ability of the Japanese version of the Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q).
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Discrimination between patients with PEI and healthy adults as assessed by the Japanese version of the PEI-Q
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
1) Patients aged 18 years or older with symptoms of PEI within the past 7 days
2) Patients who have provided voluntary written informed consent to participate in this study
Key exclusion criteria
1) Patients with any past or current gastrointestinal disorders
2) Patients with a history of any gastrointestinal surgery within the past 5 years
3) Patients who were considered ineligible for study participation by the principal investigator
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Isayama |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
113-8431
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5802-1060
h-isayama@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Ishii |
Organization
Viatris Pharmaceuticals Japan G.K.
Division name
Medical Affairs
Zip code
106-0041
Address
1-3-1, Azabudai, Minato-ku, Tokyo, Japan
TEL
03-5656-0400
Homepage URL
ryo.ishii@viatris.com
Sponsor or person
Institute
Viatris Pharmaceuticals Japan G.K.
Institute
Department
Personal name
Funding Source
Organization
Viatris Pharmaceuticals Japan G.K.
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 Ethics Committee, Faculty of Medicine, Juntendo University
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-3814-5672
jcrtc_operation@juntendo.ac.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
| 2026 | Year | 03 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This multicenter prospective observational study will evaluate the discriminative ability of the Japanese version of the PEI-Q between patients with PEI and healthy adults. Patients with PEI will be enrolled if they visit the study sites during the study period and meet the eligibility criteria. Healthy adults will be recruited and enrolled if they meet the eligibility criteria.
Management information
Registered date
| 2026 | Year | 03 | Month | 02 | Day |
Last modified on
| 2026 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069565
