A Study to Assess the Analgesic Properties of a Sublingual Wafer Formulation of Ketamine Following Third Molar 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

This is a Phase 2, randomized, multicenter, parallel group, double-blind, 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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Placebo; Drug: ketamine 25 mg; Drug: ketamine 35 mg; Drug: ketamine 50 mg

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Pasadena, California, United States, 91105
      • Lotus Clinical Research, LLC
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Prahealthsciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

18- 38 years of age 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: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; placebo
Active Comparator: ketamine 25 mg; ketamine	Drug: ketamine 25 mg; ketamine
Active Comparator: ketamine 35 mg; ketamine	Drug: ketamine 35 mg; ketamine
Active Comparator: ketamine 50 mg; ketamine	Drug: ketamine 50 mg; ketamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sum of Pain Intensity Difference	The primary objective of this study is to demonstrate the dose-response relationship for analgesia of three 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	SPID 6	6 hours
Safety and tolerability	Safety and tolerability of ketamine sublingual wafer as evaluated with physical examination, vital signs, pulse oximetry, clinical laboratory tests, ECGs, and incidence of Adverse Events (AEs) and Serious AEs (SAEs)	6 hours

Collaborators and Investigators

• Sponsor: Lotus Clinical Research, LLC
• Collaborators: iX Biopharma Ltd.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: July 23, 2014
• First Submitted That Met QC Criteria: July 23, 2014
• First Posted (Estimate): July 24, 2014

Study Record Updates

• Last Update Posted (Estimate): November 21, 2014
• Last Update Submitted That Met QC Criteria: November 19, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• 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: KET003