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Completed

NCT Number: NCT02356965

Study Testing Ketamine Sublingual Wafer After Wisdom Tooth 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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–38 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketamine

Drug

Single dose of sublingual investigational medication administered when subjects develop moderate to severe pain after third molar extraction.

Placebo (for Ketamine)

Drug

Sublingual sugar pill developed to mimic ketamine sublingual dose.

Other names: Sugar pill

Primary outcomes

  1. Sum of Pain Intensity Difference

    Time frame: 3 hours

    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.

Secondary outcomes

  1. Sum of Pain Intensity Difference

    Time frame: 6 hours

    Summed Pain Intensity Difference at 6 hours (SPID 6).

  2. 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).

    Time frame: 8 hours

    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).

Sponsors and collaborators

Lead sponsor

iX Biopharma Ltd.

Other

Collaborators

  • Jean Brown Research
  • Lotus Clinical Research, LLC

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 6, 2015
Registry last updated
Mar 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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