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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00492388
• Other study ID #: KET-016
• Status: Terminated
• Phase: Phase 3
• First received: June 26, 2007
• Last updated: January 10, 2012
• Start date: June 2007
• Est. completion date: August 2011

Study information

• Verified date: January 2012
• Source: Hospira, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breakthrough Pain
• Cancer
• Pain

Intervention

Drug:
• PMI-150 (intranasal ketamine)
intranasal dosing
• placebo
placebo

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Hospira, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain intensity difference		60 minutes	No
Secondary	various pain assessments		60 minutes	No