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MRE0094

Phase 2

Foot Ulcer, Diabetic | Small molecule | Metabolic |Pfizer, Inc.|Last Updated: Jun 1, 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-BlindUNCONTROLLED
Total Trials1
Total Enrollment322
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00312364Safety and Efficacy Study of MRE0094 to Treat Chronic, Neuropathic, Diabetic Foot UlcersPHASE2 COMPLETED 322 — — Dec 1, 2005Dec 1, 2007Jun 1, 201263 United States
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Study Endpoints
Primary Endpoints
Incidence of complete healing of target ulcer at endpoint or 90 days, whichever is earlier.
Secondary Endpoints
Time to closure and percent reduction in surface area of the target ulcer.
Incidence, intensity, and seriousness of adverse events. Changes in irritation scores.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
MRE0094DRUG -
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Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites63

Inclusion Criteria: Participants included in the study must: * Have type 1 or type 2 diabetes mellitus. * Have problems with the nerves in their feet. * Have an ulcer on the bottom surface of their foot that has been present for 3 weeks or more and is of sufficient size to qualify for the study. *...

Countries:United States
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