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Study Testing Ketamine Sublingual Wafer After Wisdom Tooth Extraction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE January 29, 2015
First Posted Date  ICMJE February 6, 2015
Last Update Posted Date March 26, 2015
Study Start Date  ICMJE December 2014
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2015)
  • Sum of Pain Intensity Difference [ Time Frame: 6 hours ]
    Summed Pain Intensity Difference at 6 hours (SPID 6).
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Testing Ketamine Sublingual Wafer After Wisdom Tooth Extraction
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: Ketamine
    Single dose of sublingual investigational medication administered when subjects develop moderate to severe pain after third molar extraction.
  • Drug: Placebo (for Ketamine)
    Sublingual sugar pill developed to mimic ketamine sublingual dose.
    Other Name: Sugar pill
Study Arms  ICMJE
  • Experimental: Ketamine 70 mg Sublingual Wafer
    Single dose of 70 mg ketamine sublingual wafer
    Intervention: Drug: Ketamine
  • Experimental: Ketamine 100 mg Sublingual Wafer
    Single dose of 100 mg ketamine sublingual wafer
    Intervention: Drug: Ketamine
  • Placebo Comparator: Placebo
    Single dose of placebo sublingual wafer
    Intervention: Drug: Placebo (for Ketamine)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2015)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE Healthy male and female subjects, ages 18-38 years old, who are scheduled to undergo two ipsilateral third molar extractions.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 38 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02356965
Other Study ID Numbers  ICMJE KET005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party iX Biopharma Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE iX Biopharma Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Jean Brown Research
  • Lotus Clinical Research, LLC
Investigators  ICMJE
Principal Investigator: Derek D Muse, MD Jean Brown Research
PRS Account iX Biopharma Ltd.
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP