Recent Updates
Recently added Catalysts

Paracetamol

Phase 3

Pain, Postoperative | Small molecule | Pain |Baxter International Inc.|Last Updated: Aug 11, 2011

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
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment148
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00508495Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-Containing Solutions in Post-Surgical Hip Replacement PainPHASE3 COMPLETED 148Aug 1, 2007Mar 1, 2008Aug 11, 20118 Hungary
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Amount of PCA-administered morphine consumed during first six hours of study drug treatment
6 hours from first (of four) study drug doses
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Test drugEXPERIMENTAL -
Reference drugACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Paracetamol (acetaminophen)DRUGFour 100 mL, 15 min IV infusions at six hour intervals
Paracetamol 1% solutionDRUGFour 100 mL, 15 min IV infusions at six hour intervals
0.9% sodium chloride solutionDRUGFour 100 mL, 15 min IV infusions at six hour intervals
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * ASA I, II or III and scheduled for elective total hip replacement, using a standard approach and a cemented implant. * Moderate or severe pain within 4 hours after stopping the PCA in the morning of the first post-operative day. Exclusion Criteria: * Another acute or chronic...

Countries:Hungary
Unlock Eligibility Criteria