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

This study has been terminated.

(Business decision not to continue development)

Sponsor:

Information provided by (Responsible Party):

Hospira, Inc.

ClinicalTrials.gov Identifier:

NCT00492388

First received: June 26, 2007

Last updated: January 10, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 26, 2007

Last Updated Date

January 10, 2012

Start Date ^ICMJE

June 2007

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

pain intensity difference [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

pain intensity difference [ Time Frame: 60 minutes ]

Change History

Complete list of historical versions of study NCT00492388 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

various pain assessments [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

various pain assessments [ Time Frame: 60 minutes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Pain
Cancer

Intervention ^ICMJE

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

Study Arm (s)

Experimental: A
PMI-150 (intranasal ketamine)

Intervention: Drug: PMI-150 (intranasal ketamine)
Placebo Comparator: B
placebo

Intervention: Drug: placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

August 2011

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00492388

Other Study ID Numbers ^ICMJE

KET-016

Has Data Monitoring Committee

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Hospira, Inc.

Study Sponsor ^ICMJE

Hospira, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Zahid Bajwa, MD

Beth Israel Deaconess Medical Center

Information Provided By

Hospira, Inc.

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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