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Pancreatin

Phase 3

Pancreatic Insufficiency | Small molecule | Gastrointestinal |Abbott Laboratories|Last Updated: Aug 18, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment62
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00705978Creon 40,000 for Treatment of PEI (Pancreatic Exocrine Insufficiency) Due to Chronic PancreatitisPHASE3 COMPLETED 62 — — Jun 1, 2008May 1, 2010Aug 18, 201111 India
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Study Endpoints
Primary Endpoints
Change in CFA from baseline to the end of double blind treatment
7 days after baseline
Secondary Endpoints
CNA, stool fat, stool weight, nutritional, clinical symptomatology, SF-36, BMI
7 days after baseline, and end of open-label period (1 year of open label treatment)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
PancreatinDRUGPancreatin with 40000 lipase units per capsule, 2 capsules per main meal (3 main meals) plus 1 capsule per snack (2-3 snacks)
PlaceboDRUGplacebo
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria * Pancreatic exocrine insufficiency has to be proven (in medical history) by a pancreatic function test * Chronic pancreatitis has to be proven (in medical history) by CT, ERCP, plain film with pancreatic calcifications, ultrasonography (calcifications,duct dilatation) and /or hi...

Countries:India
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