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

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Comparing the Efficacy and Safety of PMI-150 (Intranasal Ketamine) to Placebo as an Analgesic for the Treatment of Breakthrough Pain in Cancer Patients

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00492388

Enrollment

Registered

2007-06-27

Start date

2007-06-30

Completion date

2011-08-31

Last updated

2012-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Pain

Keywords

breakthrough, pain, cancer

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.

Detailed description

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

Interventions

DRUGplacebo

placebo

DRUGPMI-150 (intranasal ketamine)

intranasal dosing

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
pain intensity difference	60 minutes

Secondary

Measure	Time frame
various pain assessments	60 minutes

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026