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

June 26, 2007
January 10, 2012
June 2007
August 2011   (final data collection date for primary outcome measure)
pain intensity difference [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
pain intensity difference [ Time Frame: 60 minutes ]
Complete list of historical versions of study NCT00492388 on ClinicalTrials.gov Archive Site
various pain assessments [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
various pain assessments [ Time Frame: 60 minutes ]
Not Provided
Not Provided
 
Safety and Efficacy of PMI-150 (Intranasal Ketamine) for the Treatment of Breakthrough Pain in Cancer Patients
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

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

The primary objective is to evaluate the safety and efficacy following the administration of intranasal ketamine in providing pain relief as compared to placebo.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Pain
  • Cancer
  • Drug: PMI-150 (intranasal ketamine)
    intranasal dosing
  • Drug: placebo
    placebo
  • Experimental: A
    PMI-150 (intranasal ketamine)
    Intervention: Drug: PMI-150 (intranasal ketamine)
  • Placebo Comparator: B
    placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00492388
KET-016
No
Hospira, Inc.
Hospira, Inc.
Not Provided
Principal Investigator: Zahid Bajwa, MD Beth Israel Deaconess Medical Center
Hospira, Inc.
January 2012

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