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

Phase 3

Terminated

• Conditions: Pain; Cancer
• Interventions: Drug: PMI-150 (intranasal ketamine); Drug: placebo

• Registration Number: NCT00492388
• Lead Sponsor: Hospira, now a wholly owned subsidiary of Pfizer

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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-26
• Study First Submitted QC: 2007-06-26
• Study First Posted: 2007-06-27
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-10
• Last Update Posted: 2012-01-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	PMI-150 (intranasal ketamine)	PMI-150 (intranasal ketamine)
B	placebo	placebo

Primary Outcome Measures

Name	Time	Method
pain intensity difference	60 minutes

Secondary Outcome Measures

Name	Time	Method
various pain assessments	60 minutes

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States