Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:11 AM
Ignite Modification Date:
2025-12-25 @ 12:11 AM
NCT ID:
NCT05551858
Eligibility Criteria:
Subjects are eligible with a history of chronic pancreatitis as defined by the Cambridge radiographic classification with abnormal pancreatic side branches but without main pancreatic duct obstructing calcifications.
Inclusion Criteria:
* Males or females age 18 to 75 years of age
* Clinical symptoms of chronic pancreatitis
* Plus confirmation of chronic pancreatitis with imaging (Cambridge classification), EUS, biopsy, or fecal elastase \<200µg/g, or abnormal 72 hr fecal fat and radiographic evidence of CP.
* Pain not adequately controlled with medications
* Pain of at least 5 on a numeric pain scale of 0-10
* Stable doses of anti-diabetic medication for at least 90 days prior to screening.
* Women of childbearing potential unless surgically sterile or using adequate contraception (either IUD, oral or deport contraceptive, or barrier plus spermicide).
* Both males and females must be willing and able to continue contraception to prevent pregnancy for 3 months after the completion of the study.
Exclusion Criteria:
* Currently abusing alcohol (more than three drinks in a day or more than seven drinks per week) or nonprescription drugs
* Pregnant or lactating, or unwilling to prevent pregnancy
* Renal insufficiency; CKD; GFR\<60
* Unable to sign consent or maintain a diary
* Liver enzymes \> 2x ULN, Hgb \<8.5, Creat\>2; HgbA1c\>8
* Type 1 Diabetes
* Subjects with confirmed cirrhosis
* Evidence of active gallbladder disease or gallbladder dyskinesia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05551858
Study Brief:
Protocol Section:
NCT05551858