CompletedPhase 3ketamine
Safety and Efficacy of Repeated Doses of PMI-150 (Intranasal Ketamine) in Acute Post-operative Pain Following Orthopedic Surgery
Sponsored by Hospira, now a wholly owned subsidiary of Pfizer
NCT ID
NCT00709436
Target Enrollment
250 participants
Start Date
2008-06
Est. Completion
2011-08
About This Study
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.
Conditions Studied
Interventions
- •PMI-150 (intranasal ketamine)
- •Placebo
Eligibility
Age:18 Years - 85 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria: * patient is scheduled for elective orthopedic surgery or procedure Exclusion Criteria: * 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
Study Locations (16)
Jefferson Clinic
Birmingham, Alabama, United States
Shoals Clinical Research
Florence, Alabama, United States
Helen Keller Hospital
Sheffield, Alabama, United States
Arizona Research Center
Phoenix, Arizona, United States
Vertex Clinical Research
Bakersfield, California, United States
California Clinical Research
Davis, California, United States
CORE Orthopedic Medical Center
Encinitas, California, United States
JDP Medical
Aurora, Colorado, United States
Southeastern Center for Clinical Research
Atlanta, Georgia, United States
Chesapeake Research Group
Pasadena, Maryland, United States
+6 more locations