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CJ-023,423

Phase 1

Osteoarthritis | Small molecule | Musculoskeletal |Pfizer, Inc.|Last Updated: Mar 24, 2008

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_CONTROLLED
Total Trials1
Total Enrollment340
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00392080A Study Of The Effect Of CJ-023,423 On The Incidence Of Stomach UlcersPHASE1 COMPLETED 340 — — Nov 1, 2006Feb 1, 2008Mar 24, 200811 United States
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Study Endpoints
Primary Endpoints
The primary endpoint is the presence of gastroduodenal ulcers in each subject, as determined by a UGI endoscopy at the end of the treatment
7 days
Secondary Endpoints
Incidence of treatment-emergent, all-causality GI body system adverse events
Duration of trial
Severity of Dyspepsia Assessment (SODA)
Duration of trial
Post treatment gastric, duodenal and gastroduodenal endoscopic scores (according to the mucosal grading scale). The gastroduodenal score is defined as the higher of the gastric and duodenal scores.
Duration of trial
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
3PLACEBO_COMPARATOR -
1EXPERIMENTAL75 mg BID
2EXPERIMENTAL -
Interventions
NameTypeDescription
CJ-023,423DRUG75 mg BID
placeboDRUGplacebo
naproxenDRUGnaproxen
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersYes
Study Sites11

Inclusion Criteria: * Is a healthy adult 18 to 75 years of age, inclusive; healthy is defined as no clinically relevant abnormalities identified as detailed medical history, full physical examination, including blood pressure \[BP\] and pulse rate \[PR\]measurement, 12-lead electrocardiogram \[ECG\...

Countries:United States
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Competitive Landscape -Osteoarthritis 115 trials
CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY3PHASE3Eloralintide, Orforglipron, LY3016859 ISA, LY3556050 ISA, LY3526318 ISA
Pacira Biosciences, Inc.PCRX4PHASE3ZILRETTA, Enekinragene Inzadenovec, FX201
Novo Nordisk A/S Sponsored ADR Class BNVO1PHASE3NNC0487-0111
Bioventus, Inc. Class ABVS1PHASE2PTP-001
Enlivex Ltd.ENLV2PHASE1Allocetra, Allocetra-OTS
Smith & Nephew plc Sponsored ADRSNN10 — Undisclosed
Stryker CorporationSYK11NAUndisclosed
Zimmer Biomet Holdings, Inc.ZBH57NAUndisclosed
Merit Medical Systems, Inc.MMSI1NACorticosteroid
Johnson & JohnsonJNJ1NAUndisclosed
Abbott LaboratoriesABT1NAUndisclosed
Enovis CorporationENOV1NAUndisclosed
Teleflex IncorporatedTFX1 — Undisclosed
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