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SAF312A

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment183

FDA Designations

No designations recorded

Clinical trial landscape

SAF312A · 1 trial · 1 indication

Phase 2 1
NCT00986882To Evaluate the Safety, Tolerability and Analgesic Efficacy of SAF312 in Postoperative Dental Pain PatientsPostoperative Pain
COMPLETED183 Analytics
PHASE2COMPLETED
To Evaluate the Safety, Tolerability and Analgesic Efficacy of SAF312 in Postoperative Dental Pain Patients
Postoperative PainUnlock trial analytics

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 to 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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Frequently asked questions about SAF312A

What is SAF312A used for?

SAF312A is an investigational small molecule being developed for the treatment of postoperative pain. It is currently in Phase 2 clinical development, with a completed trial evaluating its safety, tolerability, and analgesic efficacy in patients with postoperative dental pain.

Who makes SAF312A?

SAF312A is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company conducted a Phase 2 clinical trial of SAF312A in the United States.

What phase is SAF312A in?

SAF312A is in Phase 2 clinical development for postoperative pain. It is an investigational drug, not yet approved by regulatory authorities. One Phase 2 trial has been completed, involving 183 participants, and no active trials are currently listed.

What clinical trials is SAF312A in?

SAF312A has one completed clinical trial registered as NCT00986882, titled "To Evaluate the Safety, Tolerability and Analgesic Efficacy of SAF312 in Postoperative Dental Pain Patients." This Phase 2, randomized, double-blind, placebo-controlled study enrolled 183 adults in the United States.

Is SAF312A the same as SAF312?

Yes, SAF312A is the same compound as SAF312. The clinical trial NCT00986882 refers to the drug as SAF312, while the drug name SAF312A is used in development records. Both names refer to the same investigational small molecule for postoperative pain.