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

Pain, Postoperative Clinical Trial

Official title:

Randomized, Multiple-center, Double-blind, Placebo-controlled Study of the Safety and Analgesic Efficacy of Repeated Dosing of PMI-150 (Intranasal Ketamine) to Treat Acute Post-operative Pain Following Orthopedic Trauma, Injury, or Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00709436
• Other study ID #: KET-017
• Status: Completed
• Phase: Phase 3
• First received: July 1, 2008
• Last updated: January 10, 2012
• Start date: June 2008
• Est. completion date: August 2011

Study information

• Verified date: January 2012
• Source: Hospira, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Allegehny Pain Management	Altoona	Pennsylvania
United States	Southeastern Center for Clinical Research	Atlanta	Georgia
United States	JDP Medical	Aurora	Colorado
United States	Vertex Clinical Research	Bakersfield	California
United States	Jefferson Clinic	Birmingham	Alabama
United States	The Ohio State University	Columbus	Ohio
United States	California Clinical Research	Davis	California
United States	CORE Orthopedic Medical Center	Encinitas	California
United States	Shoals Clinical Research	Florence	Alabama
United States	Comprehensive Pain Specialists	Hendersonville	Tennessee
United States	Chesapeake Research Group	Pasadena	Maryland
United States	Arizona Research Center	Phoenix	Arizona
United States	Jean Brown Research	Salt Lake City	Utah
United States	Helen Keller Hospital	Sheffield	Alabama
United States	University Orthopedics	State College	Pennsylvania
United States	Scott and White Memorial Hospital	Temple	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Hospira, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measures of pain intensity difference		0-6 hours	No