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Study Testing Ketamine Sublingual Wafer After Wisdom Tooth Extraction

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ClinicalTrials.gov Identifier: NCT02356965
Recruitment Status : Completed
First Posted : February 6, 2015
Last Update Posted : March 26, 2015
Sponsor:
Collaborators:
Jean Brown Research
Lotus Clinical Research, LLC
Information provided by (Responsible Party):
iX Biopharma Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Drug: Ketamine Drug: Placebo (for Ketamine) Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : December 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

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 Name: Sugar pill




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
Healthy male and female subjects, ages 18-38 years old, who are scheduled to undergo two ipsilateral third molar extractions.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02356965


Locations
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United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
iX Biopharma Ltd.
Jean Brown Research
Lotus Clinical Research, LLC
Investigators
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Principal Investigator: Derek D Muse, MD Jean Brown Research

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Responsible Party: iX Biopharma Ltd.
ClinicalTrials.gov Identifier: NCT02356965     History of Changes
Other Study ID Numbers: KET005
First Posted: February 6, 2015    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015

Keywords provided by iX Biopharma Ltd.:
Third molar extraction
Wisdom tooth extraction

Additional relevant MeSH terms:
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Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action