Safety and Efficacy of PMI-150 (Intranasal Ketamine) for the Treatment of Breakthrough Pain in Cancer Patients
Primary Purpose
Pain, Cancer
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
PMI-150 (intranasal ketamine)
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring breakthrough, pain, cancer
Eligibility Criteria
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
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A
B
Arm Description
PMI-150 (intranasal ketamine)
placebo
Outcomes
Primary Outcome Measures
pain intensity difference
Secondary Outcome Measures
various pain assessments
Full Information
NCT ID
NCT00492388
First Posted
June 26, 2007
Last Updated
January 10, 2012
Sponsor
Hospira, now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00492388
Brief Title
Safety and Efficacy of PMI-150 (Intranasal Ketamine) for the Treatment of Breakthrough Pain in Cancer Patients
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 Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Terminated
Why Stopped
Business decision not to continue development
Study Start Date
June 2007 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospira, now a wholly owned subsidiary of Pfizer
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Cancer
Keywords
breakthrough, pain, cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
PMI-150 (intranasal ketamine)
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
PMI-150 (intranasal ketamine)
Intervention Description
intranasal dosing
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
pain intensity difference
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
various pain assessments
Time Frame
60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zahid Bajwa, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of PMI-150 (Intranasal Ketamine) for the Treatment of Breakthrough Pain in Cancer Patients
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