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

Phase 3

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: PMI-150 (intranasal ketamine); Drug: Placebo

• Registration Number: NCT00709436
• Lead Sponsor: Hospira, now a wholly owned subsidiary of Pfizer

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.

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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-07-01
• Study First Submitted QC: 2008-07-01
• Study First Posted: 2008-07-03
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-10
• Last Update Posted: 2012-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	PMI-150 (intranasal ketamine)	PMI-150 (intranasal ketamine) at time 0 and specified time points thereafter.
2	Placebo	Placebo at time 0 and specified time points thereafter.

Primary Outcome Measures

Name	Time	Method
Measures of pain intensity difference	0-6 hours

Trial Locations

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

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