Safety and Efficacy of Repeated Doses of PMI-150 (Intranasal Ketamine) in Acute Post-operative Pain Following Orthopedic Surgery
NCT ID: NCT00709436
Last Updated: 2012-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
250 participants
INTERVENTIONAL
2008-06-30
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
PMI-150 (intranasal ketamine) at time 0 and specified time points thereafter.
PMI-150 (intranasal ketamine)
PMI-150 (intranasal ketamine) at time 0 and scheduled times thereafter.
2
Placebo at time 0 and specified time points thereafter.
Placebo
Placebo (intranasal) at time 0 and scheduled times thereafter.
Interventions
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PMI-150 (intranasal ketamine)
PMI-150 (intranasal ketamine) at time 0 and scheduled times thereafter.
Placebo
Placebo (intranasal) at time 0 and scheduled times thereafter.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
85 Years
ALL
No
Sponsors
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Hospira, now a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Javelin Pharmaceuticals
Role: STUDY_DIRECTOR
Javelin Pharmaceuticals
Locations
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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
The Ohio State University
Columbus, Ohio, United States
Allegehny Pain Management
Altoona, Pennsylvania, United States
University Orthopedics
State College, Pennsylvania, United States
Comprehensive Pain Specialists
Hendersonville, Tennessee, United States
Scott and White Memorial Hospital
Temple, Texas, United States
Jean Brown Research
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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KET-017
Identifier Type: -
Identifier Source: org_study_id
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