Recent Updates
Recently added Catalysts

open fracture reduction

Phase 2

Trauma | Unknown | Other |Baxter International Inc.|Last Updated: Mar 16, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment201
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00533793Adjunctive Therapy to Treat Tibial Shaft FracturesPHASE2 COMPLETED 201 — — Apr 1, 2007May 1, 2011Mar 16, 201249 Bulgaria, Czechia +10
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Clinical Criteria:weight bearing,red.pain,walking without aid;lack of need for surg. interv. fracture site;Radiogr. crit.:Cortical bridging,disintegration/disappearance fracture lines,absence of signs for complications(infection,malunion)
short term follow-up: 6 months; long term follow-up: additional 6 months (total duration of 1 year)
Secondary Endpoints
Prop. patients healed 3,9,12 mths after T0; prop. time, extent radiogr. union for 2,3,4,5,6,9,12 mths after T0; Eval.:6 and 12 mths; prop./invasiven. sec. interv. due to persistent non-union within 6,12 mths after T0.
short term follow-up: 6 months; long term follow-up: additional 6 months (1 year)
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SoCACTIVE_COMPARATORStandard of Care
SoC plus 0.133 mg/mLACTIVE_COMPARATOR -
SoC plus 0.4 mg/mLACTIVE_COMPARATOR -
SoC plus 1.0 mg/mLACTIVE_COMPARATOR -
Interventions
NameTypeDescription
open fracture reductionPROCEDUREinternal fracture fixation: osteosynthesis plates or intra-medullary nails
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites49

Inclusion Criteria: Eligible patients must meet all of the following inclusion criteria: 1. patients with an acute open fracture of the tibial shaft secondary to trauma assessed by medical examination and current radiographs indicated for open fracture reduction and internal fixation using osteosy...

Countries:BulgariaCzechiaFinlandFranceGermanyHungaryItalyRomaniaSerbiaSlovakiaSloveniaSwitzerland
Unlock Eligibility Criteria
Competitive Landscape -Trauma and Injury 9 trials
CompanyTickerTrialsLead PhaseDrugs
Humacyte, Inc.HUMA1PHASE2Human Acellular Vessel
Zimmer Biomet Holdings, Inc.ZBH1 — Undisclosed
CytoSorbents CorporationCTSO1 — Undisclosed
Unity Health TorontoUBX2NAWhole Blood, RBC + plasma
Unlock Competitive Intelligence