MedTrace Logo

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

NCT00709436 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2012-01-11

No results posted yet for this study

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.

Conditions

  • Pain, Postoperative

Interventions

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.

Sponsors & Collaborators

  • Hospira, now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Principal Investigators

  • Javelin Pharmaceuticals · Javelin Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00709436 on ClinicalTrials.gov