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Pancreatic Enzyme Supplementation in Unresectable Pancreatic Cancer
NCT01587534Phase 2
Key facts
- Status
- Completed
- Start
- Oct 2011
- Primary completion
- Dec 2014
- Countries
- 1
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- pancreatin
- Conditions
- exocrine pancreatic insufficiency (EPI)
01
Overview
Phase 2, randomised, double-blind trial in exocrine pancreatic insufficiency (EPI) comparing Norzyme with Placebo (2 arms). Primary endpoint: Change in body weight at 8 weeks. Started Oct 2011; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Norzyme
Pancreatic enzyme replacement therapy (Norzyme) 6-9 tablets/day
Placebo
Placebo matching active drug
03
Who it enrols
Patients with unresectable pancreatic cancer, age > 18, ECOG 0-2, excluding those with major GI surgery, chronic GI disease, decompensated diabetes, or use of drugs affecting motility or acidity.
04
Endpoints
Primary
Change in body weight
Secondary
Frequency and intensity of abdominal pain daily
Frequency of bowel movements per day
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