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SAF312A

Phase 2

Postoperative Pain | Small molecule | Pain |Novartis AG|Last Updated: Dec 19, 2020

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment183
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00986882To Evaluate the Safety, Tolerability and Analgesic Efficacy of SAF312 in Postoperative Dental Pain PatientsPHASE2 COMPLETED 183Sep 1, 2009Mar 1, 2011Dec 19, 20201 United States
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Study Endpoints
Primary Endpoints
To evaluate the safety, tolerability, efficacy and dose response of single oral doses of SAF312 in patients with postoperative dental pain
24 hours
Secondary Endpoints
To assess the pharmacokinetics of the single oral doses of SAF312 and Ibuprofen in patients with postoperative dental pain
24 hours
To measure: time-specific pain relief (PR), Total pain relief (TOTPAR), time to onset of analgesia, time to rescue medication
24 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SAF312A (2 doses in part B; 5 - 6 doses in part C)EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
IbuprofenACTIVE_COMPARATOR -
Interventions
NameTypeDescription
SAF312ADRUG -
PlaceboDRUG -
IbuprofenDRUG -
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Extraction of two or more impacted (partial or full) third molars. At least one of the impaction should be lower jaw. * Each patient will evaluate her/his post-surgical pain intensity prior to taking trial medication. * To be eligible for this trial, post surgical pain must be...

Countries:United States
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