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

Ketamine

Brief Summary

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.

Intervention / Treatment

  • Placebo (DRUG)
    placebo
  • ketamine 25 mg (DRUG)
    ketamine
  • ketamine 35 mg (DRUG)
    ketamine
  • ketamine 50 mg (DRUG)
    ketamine

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: 120 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Investigator

    Clinical Trial Dates

    Start date: Jul 01, 2014
    Primary Completion: Nov 01, 2014 ACTUAL
    Completion Date: Nov 01, 2014 ACTUAL
    Study First Posted: Jul 24, 2014 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Nov 19, 2014

    Sponsors / Collaborators

    Lead Sponsor: Lotus Clinical Research, LLC
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Salt Lake City, Utah, USA
    Pasadena, California, USA

    Participant Groups

    • Placebo

    • ketamine

    • ketamine

    • ketamine

    Eligibility Criteria

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

    18- 38 years of age Scheduled to undergo two ipsilateral third molar extractions

    Primary Outcomes

    • 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.

    Secondary Outcomes

    • SPID 6

    • 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)

    More Details

    NCT Number: NCT02199678
    Other IDs: KET003
    Study URL: https://clinicaltrials.gov/study/NCT02199678
    Last updated: Sep 29, 2023