Study Testing Ketamine Sublingual Wafer After Wisdom Tooth Extraction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Dose Ranging Study to Assess the Analgesic Efficacy, Tolerability, Safety and Pharmacokinetic/Pharmacodynamic Properties of A Sublingual Wafer Formulation of Ketamine Following Third Molar Extraction

Conditions
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Pain

Intervention / Treatment
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* Drug: Ketamine
* Drug: Placebo (for Ketamine)


Participation Criteria
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Eligibility Criteria
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Healthy male and female subjects, ages 18-38 years old, who are scheduled to undergo two ipsilateral third molar extractions.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine 70 mg Sublingual Wafer<br>Single dose of 70 mg ketamine sublingual wafer | Drug: Ketamine<br>* Single dose of sublingual investigational medication administered when subjects develop moderate to severe pain after third molar extraction.<br>|
| Experimental: Ketamine 100 mg Sublingual Wafer<br>Single dose of 100 mg ketamine sublingual wafer | Drug: Ketamine<br>* Single dose of sublingual investigational medication administered when subjects develop moderate to severe pain after third molar extraction.<br>|
| Placebo Comparator: Placebo<br>Single dose of placebo sublingual wafer | Drug: Placebo (for Ketamine)<br>* Sublingual sugar pill developed to mimic ketamine sublingual dose.<br>* Other names: Sugar pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sum of Pain Intensity Difference | Summed Pain Intensity Difference at 6 hours (SPID 6). | 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). | 8 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Third molar extraction, Wisdom tooth extraction