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)
Information provided by (Responsible Party):
Hospira, Inc. Identifier:
First received: June 26, 2007
Last updated: January 10, 2012
Last verified: January 2012
To assess the safety and efficacy of PMI-150 (Intranasal Ketamine) as an analgesic for the treatment of breakthrough pain in cancer patients.

Condition Intervention Phase
Drug: PMI-150 (intranasal ketamine)
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Further study details as provided by Hospira, Inc.:

Primary Outcome Measures:
  • pain intensity difference [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • various pain assessments [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: June 2007
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
PMI-150 (intranasal ketamine)
Drug: PMI-150 (intranasal ketamine)
intranasal dosing
Placebo Comparator: B
Drug: placebo

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: NCT00492388

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Hospira, Inc.
Principal Investigator: Zahid Bajwa, MD Beth Israel Deaconess Medical Center
  More Information

Responsible Party: Hospira, Inc. Identifier: NCT00492388     History of Changes
Other Study ID Numbers: KET-016 
Study First Received: June 26, 2007
Last Updated: January 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Hospira, Inc.:

Additional relevant MeSH terms:
Breakthrough Pain
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Anesthetics, Dissociative
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents processed this record on May 26, 2016