Study Testing Ketamine Sublingual Wafer After Wisdom Tooth Extraction

Ketamine

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.

Intervention / Treatment

  • 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.

Condition or Disease

  • Pain

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 38 Years
    Enrollment: 80 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Dec 01, 2014
    Primary Completion: Feb 01, 2015 ACTUAL
    Completion Date: Feb 01, 2015 ACTUAL
    Study First Posted: Feb 06, 2015 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Mar 24, 2015

    Sponsors / Collaborators

    Lead Sponsor: iX Biopharma Ltd.
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Salt Lake City, Utah, USA

    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.

    Participant Groups

    • Single dose of 70 mg ketamine sublingual wafer

    • Single dose of 100 mg ketamine sublingual wafer

    • Single dose of placebo sublingual wafer

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 38
    Age Groups: Adult
    Healthy Volunteers: Yes

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

    Primary Outcomes

    • 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

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

    • 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).

    More Details

    NCT Number: NCT02356965
    Other IDs: KET005
    Study URL: https://clinicaltrials.gov/study/NCT02356965
    Last updated: Sep 29, 2023