Safety and Efficacy of PMI-150 (Intranasal Ketamine) for the Treatment of Breakthrough Pain in Cancer Patients

Ketamine

Brief Summary

To assess the safety and efficacy of PMI-150 (Intranasal Ketamine) as an analgesic for the treatment of breakthrough pain in cancer patients.

Intervention / Treatment

  • PMI-150 (intranasal ketamine) (DRUG)
    intranasal dosing
  • Placebo (DRUG)
    placebo

Condition or Disease

  • Pain
  • Cancer

Phase

  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Terminated
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 2 (ACTUAL)
    Funded by: Industry
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

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

    Clinical Trial Dates

    Start date: Jun 01, 2007
    Primary Completion: Aug 01, 2011 ACTUAL
    Completion Date: Aug 01, 2011 ACTUAL
    Study First Posted: Jun 27, 2007 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

    Boston, Massachusetts, USA

    The primary objective is to evaluate the safety and efficacy following the administration of intranasal ketamine in providing pain relief as compared to placebo.

    Participant Groups

    • PMI-150 (intranasal ketamine)

    • placebo

    Eligibility Criteria

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

    Inclusion Criteria:

    * at least 18 years of age
    * Patients requiring around-the-clock opioids for pain due to cancer and with a history of experiencing episodes of breakthrough pain

    Exclusion Criteria:

    * under 18 years
    * non-cancer pain
    * allergy to ketamine

    Primary Outcomes
    • pain intensity difference 60 minutes
    Secondary Outcomes
    • various pain assessments 60 minutes

    More Details

    NCT Number: NCT00492388
    Other IDs: KET-016
    Study URL: https://clinicaltrials.gov/study/NCT00492388
    Last updated: Sep 29, 2023