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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00492388
Recruitment Status : Terminated (Business decision not to continue development)
First Posted : June 27, 2007
Last Update Posted : January 11, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Pain Cancer Drug: PMI-150 (intranasal ketamine) Drug: placebo Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : June 2007
Primary Completion Date : August 2011
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A
PMI-150 (intranasal ketamine)
Drug: PMI-150 (intranasal ketamine)
intranasal dosing
Placebo Comparator: B
Drug: placebo

Outcome Measures

Primary Outcome Measures :
  1. pain intensity difference [ Time Frame: 60 minutes ]

Secondary Outcome Measures :
  1. various pain assessments [ Time Frame: 60 minutes ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00492388

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Hospira, now a wholly owned subsidiary of Pfizer
Principal Investigator: Zahid Bajwa, MD Beth Israel Deaconess Medical Center
More Information

Responsible Party: Hospira, now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00492388     History of Changes
Other Study ID Numbers: KET-016
First Posted: June 27, 2007    Key Record Dates
Last Update Posted: January 11, 2012
Last Verified: January 2012

Keywords provided by Hospira, now a wholly owned subsidiary of Pfizer:

Additional relevant MeSH terms:
Breakthrough Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action