Safety and Efficacy of Repeated Doses of PMI-150 (Intranasal Ketamine) in Acute Post-operative Pain Following Orthopedic Surgery

Ketamine

Brief Summary

The purpose of this research study is to evaluate the safety and analgesic efficacy of PMI-150 (intranasal ketamine) compared to placebo in patients with acute post-operative pain following orthopedic trauma, injury, or surgery.

Intervention / Treatment

  • PMI-150 (intranasal ketamine) (DRUG)
    PMI-150 (intranasal ketamine) at time 0 and scheduled times thereafter.
  • Placebo (DRUG)
    Placebo (intranasal) at time 0 and scheduled times thereafter.

Condition or Disease

  • Pain, Postoperative

Phase

  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 85 Years
    Enrollment: 250 (ACTUAL)
    Funded by: Industry
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

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

    Clinical Trial Dates

    Start date: Jun 01, 2008
    Primary Completion: Aug 01, 2011 ACTUAL
    Completion Date: Aug 01, 2011 ACTUAL
    Study First Posted: Jul 03, 2008 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Jan 10, 2012

    Sponsors / Collaborators

    Lead Sponsor: N/A
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Atlanta, Georgia, USA
    Salt Lake City, Utah, USA
    Encinitas, California, USA
    Birmingham, Alabama, USA
    Phoenix, Arizona, USA
    Aurora, Colorado, USA
    Hendersonville, Tennessee, USA
    Columbus, Ohio, USA
    Altoona, Pennsylvania, USA
    Florence, Alabama, USA
    Sheffield, Alabama, USA
    Bakersfield, California, USA
    Davis, California, USA
    Pasadena, Maryland, USA
    State College, Pennsylvania, USA
    Temple, Texas, USA

    Patients will be randomly assigned to PMI-150 (intranasal ketamine) or placebo and will receive repeated doses and be assessed for safety and efficacy.

    Participant Groups

    • PMI-150 (intranasal ketamine) at time 0 and specified time points thereafter.

    • Placebo at time 0 and specified time points thereafter.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 85
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * patient is scheduled for elective orthopedic surgery or procedure

    Exclusion Criteria:

    * patient has received an investigational drug or participated in a clinical trial within 30 days or 5 half-lives (whichever is longer) of entering this study

    Primary Outcomes
    • Measures of pain intensity difference 0-6 hours

    More Details

    NCT Number: NCT00709436
    Other IDs: KET-017
    Study URL: https://clinicaltrials.gov/study/NCT00709436
    Last updated: Sep 29, 2023