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SA-001

Phase 3

Pancreatic Exocrine Insufficiency, Chronic Pancreatitis, Pancreatectomy | Small molecule | Gastrointestinal |Abbott Laboratories|Last Updated: Aug 1, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment80
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00401076A Open-label Study to Assess the Safety of Oral Long-term Use of SA-001 in Pancreatic Exocrine InsufficiencyPHASE3 COMPLETED 80 — — Jul 1, 2008Sep 1, 2010Aug 1, 201117 Japan
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Study Endpoints
Primary Endpoints
Safety of long-term use of 3.0 g/day SA 001 (12 capsules/day), flexibly increased or decreased within the range of 1.5 g/day SA 001 (6 capsules/day) to 6.0 g/day SA-001 (24 capsules/day)
52 weeks
Secondary Endpoints
Efficacy data (nutritional evaluation items) of 3.0 g/day SA-001 (12 capsules/day), flexibly increased or decreased within the range of 1.5 g/day SA 001 (6 capsules/day) to 6.0 g/day SA-001 (24 capsules/day)
52 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
Interventions
NameTypeDescription
SA-001DRUG0.25 g of SA-001 pellets/capsule, 12 capsules/day for 52 weeks
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Eligibility Criteria
Age Range20 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria Subjects who complete the S245.3.122 clinical study (excluding discontinued subjects). Exclusion Criteria Subjects who are assessed to be inappropriate for continuing long-term use of SA-001, at the discretion of the investigator or the sub-investigator, because they experienced ...

Countries:Japan
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