Clinical trial · Interventional
A Study of Creon (Pancrelipase) in Resected and Non-resected Pancreatic Cancer Participants With Exocrine Pancreatic Insufficiency (EPI)
Creon (Pancrelipase) Therapy for Subjects With Exocrine Pancreatic Insufficiency (EPI) Due to Pancreatic Cancer: A Double-blind, Randomized, Parallel Design With 2 Dose Cohorts of Pancrelipase in Resected Pancreatic Cancer Subjects and an Open-label Single Dose Cohort in Non-resected Pancreatic Cancer Subjects
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business Considerations (difficulty with enrollment)
Summary
Brief summary (as posted)
This is a study in participants with Exocrine Pancreatic Insufficiency (EPI) due to pancreatic cancer. This study will include resected participants who are post pancreatic cancer surgery, and an additional cohort in non-resected participants.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Exocrine Pancreatic Insufficiency (EPI) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pancrelipase | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase
- description
- Resected participants (surgery to remove pancreatic cancer) will first be given low dose pancrelipase. Low dose is defined as 12,000 USP units (lipase) with meals and 6000 U with snacks. At Weeks 1, 5, or 9, participants will be evaluated, and those who meet criteria for dose increase will be given high dose pancrelipase. High dose is defined as 72,000 U with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.
- interventionNames
- Drug: Pancrelipase
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase
- description
- Resected participants (surgery to remove pancreatic cancer) will receive and continue on high dose pancrelipase throughout the study. High dose is defined as 72,000 USP units (lipase) with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Participant has diagnosed cancer of pancreas with biopsy and/or radiography, with a life expectancy of at least 5 months at screening * Participant's pancreatic cancer must involve the head and/or neck of the pancreas * Confirmed exocrine pancreatic insufficiency (EPI) as evidenced by fecal elastase-1 (FE-1) ≤ 150 µg/g stool at screening * A positive Sudan stain for participants without history of fat malabsorption (fat malabsorption is defined as clinical steatorrhea, or measured stool fat \> 7 g/day, or positive stool results by Sudan stain) within 1 week of screening -- Positive stool results are defined as increased level of neutral OR total fats Exclusion Criteria: * Participant has neuroendocrine pancreatic cancer * Participant has fibrosing colonopathy * Participant has any other malignancy within 1 year of screening * Participant has uncontrolled gout, including those with a recent flare within 60 days of screening * Participant has other significant organ or bone marrow abnormality within 60 days of screening
References
Publications (0)
Data not yet available