Status:
COMPLETED
Safety and Efficacy of Repeated Doses of PMI-150 (Intranasal Ketamine) in Acute Post-operative Pain Following Orthopedic Surgery
Lead Sponsor:
Hospira, now a wholly owned subsidiary of Pfizer
Conditions:
Pain, Postoperative
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
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...
Detailed Description
Patients will be randomly assigned to PMI-150 (intranasal ketamine) or placebo and will receive repeated doses and be assessed for safety and efficacy.
Eligibility Criteria
Inclusion
- patient is scheduled for elective orthopedic surgery or procedure
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00709436
Start Date
June 1 2008
End Date
August 1 2011
Last Update
January 11 2012
Active Locations (16)
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1
Jefferson Clinic
Birmingham, Alabama, United States, 35233
2
Shoals Clinical Research
Florence, Alabama, United States, 35630
3
Helen Keller Hospital
Sheffield, Alabama, United States, 25660
4
Arizona Research Center
Phoenix, Arizona, United States, 85023