The purpose of the study is to test two different doses of ketamine sub-lingual (under the tongue) wafer against placebo to see how effective the medication is to treat moderate to severe pain after wisdom tooth extraction.
This is a Phase 2, randomized, double-blind, parallel group, dose-ranging placebo-controlled evaluation of the analgesic efficacy, safety and pharmacokinetics of ketamine sublingual wafer in adult subjects who experience post-operative pain after undergoing third molar extraction. The study will enroll approximately 80 subjects at a single site. Subjects will be at least 18 years to 38 years of age. Subjects will receive a single dose of 70 mg or 100 mg sublingual ketamine wafer or placebo. Efficacy assessment will include pain intensity, use of rescue medication, and Patient Global Assessment (PGA) of pain control. Safety assessments will include monitoring of AEs and SAEs, clinical laboratory tests, vital sign measurements, oral assessments, and ECGs. A maximum of eight 4ml blood samples will be taken from each participant up to 8 hours after study drug administration for plasma analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Single dose of sublingual investigational medication administered when subjects develop moderate to severe pain after third molar extraction.
Sublingual sugar pill developed to mimic ketamine sublingual dose.
Jean Brown Research
Salt Lake City, Utah, United States
Sum of Pain Intensity Difference
Demonstrate the dose-response relationship for analgesia of two dose levels of ketamine sublingual wafer compared with placebo, using the summed pain intensity difference from baseline over the first 3 hours (SPID3) in subjects with acute moderate to severe pain following third molar extraction.
Time frame: 3 hours
Sum of Pain Intensity Difference
Summed Pain Intensity Difference at 6 hours (SPID 6).
Time frame: 6 hours
Safety and Tolerability evaluated by physical examination, vital signs, pulse oximetry, clinical laboratory tests, ECGs and Incident of Adverse Events (AEs) and Serious Adverse Events (SAEs).
Safety and tolerability of ketamine sublingual wafer as evaluated by physical examination, vital signs, pulse oximetry, clinical laboratory tests, ECGs and Incident of Adverse Events (AEs) and Serious Adverse Events (SAEs).
Time frame: 8 hours
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