Safety and Efficacy of Repeated Doses of PMI-150 (Intranasal Ketamine) in Acute Post-operative Pain Following Orthopedic Surgery
Randomized, Multiple-center, Double-blind, Placebo-controlled Study of the Safety and Analgesic Efficacy of Repeated Dosing of PMI-150 (Intranasal Ketamine) to Treat Acute Post-operative Pain Following Orthopedic Trauma, Injury, or Surgery.
1 other identifier
interventional
250
1 country
16
Brief Summary
The purpose of this research study is to evaluate the safety and analgesic efficacy of PMI-150 (intranasal ketamine) compared to placebo in patients with acute post-operative pain following orthopedic trauma, injury, or surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2008
Typical duration for phase_3
16 active sites
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, 2008
CompletedFirst Submitted
Initial submission to the registry
July 1, 2008
CompletedFirst Posted
Study publicly available on registry
July 3, 2008
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
3.2 years
July 1, 2008
January 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measures of pain intensity difference
0-6 hours
Study Arms (2)
1
EXPERIMENTALPMI-150 (intranasal ketamine) at time 0 and specified time points thereafter.
2
PLACEBO COMPARATORPlacebo at time 0 and specified time points thereafter.
Interventions
PMI-150 (intranasal ketamine) at time 0 and scheduled times thereafter.
Eligibility Criteria
You may qualify if:
- patient is scheduled for elective orthopedic surgery or procedure
You may not qualify if:
- patient has received an investigational drug or participated in a clinical trial within 30 days or 5 half-lives (whichever is longer) of entering this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Jefferson Clinic
Birmingham, Alabama, 35233, United States
Shoals Clinical Research
Florence, Alabama, 35630, United States
Helen Keller Hospital
Sheffield, Alabama, 25660, United States
Arizona Research Center
Phoenix, Arizona, 85023, United States
Vertex Clinical Research
Bakersfield, California, CA, United States
California Clinical Research
Davis, California, 95616, United States
CORE Orthopedic Medical Center
Encinitas, California, 92024, United States
JDP Medical
Aurora, Colorado, 80014, United States
Southeastern Center for Clinical Research
Atlanta, Georgia, 30350, United States
Chesapeake Research Group
Pasadena, Maryland, 21122, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Allegehny Pain Management
Altoona, Pennsylvania, 16602, United States
University Orthopedics
State College, Pennsylvania, 16801, United States
Comprehensive Pain Specialists
Hendersonville, Tennessee, 37075, United States
Scott and White Memorial Hospital
Temple, Texas, 76508, United States
Jean Brown Research
Salt Lake City, Utah, 84117, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Javelin Pharmaceuticals
Javelin Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2008
First Posted
July 3, 2008
Study Start
June 1, 2008
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
January 11, 2012
Record last verified: 2012-01