Study Stopped
Business decision not to continue development
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
1 other identifier
interventional
2
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 pain
Started Jun 2007
Longer than P75 for phase_3 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 26, 2007
CompletedFirst Posted
Study publicly available on registry
June 27, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedJanuary 11, 2012
January 1, 2012
4.2 years
June 26, 2007
January 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pain intensity difference
60 minutes
Secondary Outcomes (1)
various pain assessments
60 minutes
Study Arms (2)
A
EXPERIMENTALPMI-150 (intranasal ketamine)
B
PLACEBO COMPARATORplacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- under 18 years
- non-cancer pain
- allergy to ketamine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zahid Bajwa, MD
Beth Israel Deaconess Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2007
First Posted
June 27, 2007
Study Start
June 1, 2007
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
January 11, 2012
Record last verified: 2012-01