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Loxoprofen

Phase 3

Low Back Pain | Small molecule | Musculoskeletal |Pfizer, Inc.|Last Updated: Mar 3, 2021

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment1,234
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00141154Comparison Of Celecoxib 200 Mg Bid, Loxoprofen Sodium 60 Mg Tid And Placebo In Low Back Pain In JapanPHASE3 COMPLETED 1,234Oct 1, 2004 -Mar 3, 202138 Japan
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Study Endpoints
Primary Endpoints
Patient's pain assessment (VAS: Visual Analogue Scale)
Secondary Endpoints
Patient's global assessment (VAS), Physician's global assessment (VAS), Roland Morris Disability Questionnaire (RDQ)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
CelecoxibDRUG -
PlaceboDRUG -
LoxoprofenDRUG -
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Eligibility Criteria
Age Range20 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites38

Inclusion Criteria: * Patients who have the major site of the low back pain at the 12th thoracic vertebra or lower * Patients who have had low back pain for at least two weeks Exclusion Criteria: * Patients who have a previous history or complication of rheumatoid arthritis, spondylarthrosis with...

Countries:Japan
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