Safety and Efficacy of Repeated Doses of PMI-150 (Intranasal Ketamine) in Acute Post-operative Pain Following Orthopedic Surgery

Completed · Phase 3 · Has a placebo group

Conditions studied: Pain, Postoperative

In brief

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.

Key facts

Study ID

NCT00709436

Run by

Hospira, now a wholly owned subsidiary of Pfizer

People needed

250

Starts

2008-06-01

Expected to finish

2011-08-01

Last updated by the study team

2012-01-11

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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