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Ilaprazole

Phase 2

Esophagitis | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Feb 2, 2012

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-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment831
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00471094Safety and Efficacy of Ilaprazole 5, 20 and 40 mg QD and Lansoprazole 30 mg QD on Healing of Erosive EsophagitisPHASE2 COMPLETED 831May 1, 2007Oct 1, 2007Feb 2, 201294 United States
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Study Endpoints
Primary Endpoints
The crude healing rate of Erosive Esophagitis at week 4 of treatment as assessed by endoscopy.
Week 4
Secondary Endpoints
The crude healing rate of Erosive Esophagitis at week 8 of treatment as assessed by endoscopy.
Week 8
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Ilaprazole 5 mg QDEXPERIMENTAL -
Ilaprazole 20 mg QDEXPERIMENTAL -
Ilaprazole 40 mg QDEXPERIMENTAL -
Lansoprazole 30 mg QDACTIVE_COMPARATOR -
Interventions
NameTypeDescription
IlaprazoleDRUGIlaprazole 5 mg, capsules, orally, once daily for up to 8 weeks.
LansoprazoleDRUGLansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites94

Inclusion Criteria: * Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D). Exclusion Criteria: * Evidence of uncontrolled, clinically significant systemic disease; acquired immunodeficiency syndrome (AIDs); a condit...

Countries:United States
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