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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT00709436

Public ClinicalTrials.gov record NCT00709436. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 12:16 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00709436
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
250 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 85 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 2008 (Type not available)
Primary completion
Aug 2011 (Actual)
Completion
Aug 2011 (Actual)
Last update posted
Jan 11, 2012

2008 – 2011

United States locations

U.S. sites
16
U.S. states
11
U.S. cities
16
Facility City State ZIP Site status
Jefferson Clinic Birmingham Alabama 35233 —
Shoals Clinical Research Florence Alabama 35630 —
Helen Keller Hospital Sheffield Alabama 25660 —
Arizona Research Center Phoenix Arizona 85023 —
Vertex Clinical Research Bakersfield California CA —
California Clinical Research Davis California 95616 —
CORE Orthopedic Medical Center Encinitas California 92024 —
JDP Medical Aurora Colorado 80014 —
Southeastern Center for Clinical Research Atlanta Georgia 30350 —
Chesapeake Research Group Pasadena Maryland 21122 —
The Ohio State University Columbus Ohio 43210 —
Allegehny Pain Management Altoona Pennsylvania 16602 —
University Orthopedics State College Pennsylvania 16801 —
Comprehensive Pain Specialists Hendersonville Tennessee 37075 —
Scott and White Memorial Hospital Temple Texas 76508 —
Jean Brown Research Salt Lake City Utah 84117 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00709436, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 11, 2012 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00709436 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →