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Pancrelipase in combination with Ensure Plus

Phase 1

Exocrine Pancreatic Insufficiency | Small molecule | Gastrointestinal |Johnson & Johnson|Last Updated: May 19, 2011

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment13

FDA Designations

No designations recorded

Clinical trial landscape

Pancrelipase in combination with Ensure Plus · 1 trial · 4 indications

Phase 1 1
NCT00676702A Study of the Enzyme Activity and Safety of Pancrelipase in Patients With Severe Exocrine Pancreatic Insufficiency (EPI)Exocrine Pancreatic Insufficiency
COMPLETED13 Analytics
PHASE1COMPLETED
A Study of the Enzyme Activity and Safety of Pancrelipase in Patients With Severe Exocrine Pancreatic Insufficiency (EPI)
Exocrine Pancreatic Insufficiency
NCT0067670213
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Study Endpoints

Primary Endpoints

To evaluate the pharmacokinetics (enzyme activity) of intraduodenal enzyme (lipase, amylase, and protease) delivery of a single dose of 3 pancrelipase MT 21 capsules in gastric and duodenal fluid samples collected from patients
Pretreatment and at 15 minute intervals up to 2 hours posttreatment on Day 1 during each treatment period.

Secondary Endpoints

To evaluate the safety and tolerability of 3 pancrelipase MT 21 capsules containing a total of 63,000 USP units of lipase.
Time of screening (Day -21) through to the end of the study procedures performed on Day 1 of treatment period 2.
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Study Design & Arms

ModelCROSSOVER

Treatment Arms

ArmTypeDescription
001EXPERIMENTALPancrelipase in combination with Ensure Plus 3 pancrelipase MT 21 capsules containing a total of 63 000 USP units of lipase with a high-fat liquid meal of 500 ml of Ensure Plus.
002ACTIVE_COMPARATOREnsure Plus A high-fat liquid meal of 500 ml of Ensure Plus

Interventions

NameTypeDescription
Ensure PlusDIETARY_SUPPLEMENTA high-fat liquid meal of 500 ml of Ensure Plus
Pancrelipase in combination with Ensure PlusDRUG3 pancrelipase MT 21 capsules containing a total of 63,000 USP units of lipase with a high-fat liquid meal of 500 ml of Ensure Plus.
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Eligibility Criteria

Age Range18 Years to 85 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Must have evidence of chronic pancreatitis or pancreatic insufficiency (steatorrhea) confirmed prior to screening * Must be able to discontinue treatment with any pancreatic enzyme preparations (PEPs) within 72 hours before admission to the study center for the open-label phas...

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