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Paracetamol experimental

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
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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 Enrollment135
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00406679Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-containing Solutions in Post-Surgical Dental PainPHASE3 COMPLETED 135Nov 1, 2006Oct 1, 2007Aug 11, 20112 United Kingdom
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
3ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Paracetamol (acetaminophen) solution experimentalDRUG1 gm IV
paracetamol (acetaminophen) solution commercialDRUG1 gm IV
placeboDRUGequivalent volume IV 0.9% sodium chloride (equivalent volume)
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * ASA I or II and scheduled for elective surgical extraction of 1 or more impacted mandibular 3rd molars, at least 1 of which must be a fully or partially impacted mandibular 3rd molar requiring mandibular bone removal. * Moderate or severe pain within 4 hours after the completi...

Countries:United Kingdom
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