Safety and Efficacy of Repeated Doses of PMI-150 (Intranasal Ketamine) in Acute Post-operative Pain Following Orthopedic Surgery
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.
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
Conditions
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
- May 31, 2008
- Primary completion
- Jul 31, 2011
- Completion
- Jul 31, 2011
- Last update posted
- Jan 10, 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 10, 2012 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00709436 live on ClinicalTrials.gov.