Tokyo, March 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060805) titled 'Validation of the Japanese Version of the Pancreatic Exocrine Insufficiency Questionnaire' on March 2.
Study Type:
Observational
Primary Sponsor:
Institute - Viatris Pharmaceuticals Japan G.K.
Condition:
Condition - Pancreatic exocrine insufficiency
Classification by malignancy - Others
Genomic information - NO
Objective:
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
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 Size - 150
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 11 Day
Anticipated trial start date - 2026 Year 03 Month 03 Day
Last follow-up date - 2026 Year 10 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069565
Disclaimer: Curated by HT Syndication.
