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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1
Pancrelipase is administered orally as capsules with a meal or snack
Placebo is administered orally as capsules with a meal or snack
Change in Stool Fat From Baseline (Day 1) to Week 1 (Day 8) Among Participants With Resected Pancreatic Cancer
Stool samples were collected during the 48 hours prior to the Day 1 and Week 1 visits and analyzed for fat content.
Time frame: Baseline (Day 1), Week 1 (Day 8)
Change in Average Daily Stool Frequency From Baseline (Day 1) to Week 1 (Day 8) Among Participants With Resected Pancreatic Cancer
Participants recorded stool frequency using an electronic diary (eDiary). The average daily stool frequency was calculated from the last 3 days prior to the Baseline and Week 1 visits.
Time frame: Baseline (Day 1), Week 1 (Day 8)
Change in Stool Consistency From Baseline to Week 1 Among Participants With Resected Pancreatic Cancer
Participants recorded stool consistency using an electronic diary (eDiary). The change from Baseline to Week 1 is the proportion of days having watery stool consistency in the last 7 days prior to each of Baseline and Week 1 visits. Negative changes from Baseline indicate less frequent watery stools.
Time frame: Baseline (Day 1), Week 1 (Day 8)
Change in the Total EPI Symptoms Score From Baseline to Week 1 Among Participants With Resected Pancreatic Cancer
The EPI Symptoms Questionnaire consists of 12 questions. The response scores range from 0 to 4 for each question (0 corresponding to None to 4 corresponding to Very Severe), with the total score ranging from 0 to 48. Positive changes indicate worsening from Baseline.
Time frame: Baseline (Day 1), Week 1 (Day 8)
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