NCT00709436

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

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Hospira, now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	PMI-150 (intranasal ketamine)	PMI-150 (intranasal ketamine) at time 0 and scheduled times thereafter.
DRUG	Placebo	Placebo (intranasal) at time 0 and scheduled times thereafter.

Timeline

• Start date: 2008-06-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2008-07-03
• Last updated: 2012-01-11

Locations

16 sites across 1 country: United States