Study Testing Ketamine Sublingual Wafer After Wisdom Tooth Extraction

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Ketamine; Drug: Placebo (for Ketamine)

Detailed Description

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
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Jean Brown Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: iX Biopharma Ltd.
• Collaborators: Lotus Clinical Research, LLC; Jean Brown Research
• Investigators: Principal Investigator: Derek D Muse, MD, Jean Brown Research

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: January 29, 2015
• First Submitted That Met QC Criteria: February 5, 2015
• First Posted (Estimate): February 6, 2015

Study Record Updates

• Last Update Posted (Estimate): March 26, 2015
• Last Update Submitted That Met QC Criteria: March 24, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Third molar extraction; Wisdom tooth extraction
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: KET005