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

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
PMI-150 (intranasal ketamine)
Placebo
Sponsored by
Hospira, now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring orthopedic, ketamine, pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jefferson Clinic
  • Shoals Clinical Research
  • Helen Keller Hospital
  • Arizona Research Center
  • Vertex Clinical Research
  • California Clinical Research
  • CORE Orthopedic Medical Center
  • JDP Medical
  • Southeastern Center for Clinical Research
  • Chesapeake Research Group
  • The Ohio State University
  • Allegehny Pain Management
  • University Orthopedics
  • Comprehensive Pain Specialists
  • Scott and White Memorial Hospital
  • Jean Brown Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

PMI-150 (intranasal ketamine) at time 0 and specified time points thereafter.

Placebo at time 0 and specified time points thereafter.

Outcomes

Primary Outcome Measures

Measures of pain intensity difference

Secondary Outcome Measures

Full Information

First Posted
July 1, 2008
Last Updated
January 10, 2012
Sponsor
Hospira, now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00709436
Brief Title
Safety and Efficacy of Repeated Doses of PMI-150 (Intranasal Ketamine) in Acute Post-operative Pain Following Orthopedic Surgery
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospira, now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
orthopedic, ketamine, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
PMI-150 (intranasal ketamine) at time 0 and specified time points thereafter.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo at time 0 and specified time points thereafter.
Intervention Type
Drug
Intervention Name(s)
PMI-150 (intranasal ketamine)
Intervention Description
PMI-150 (intranasal ketamine) at time 0 and scheduled times thereafter.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (intranasal) at time 0 and scheduled times thereafter.
Primary Outcome Measure Information:
Title
Measures of pain intensity difference
Time Frame
0-6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javelin Pharmaceuticals
Organizational Affiliation
Javelin Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Jefferson Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Shoals Clinical Research
City
Florence
State/Province
Alabama
ZIP/Postal Code
35630
Country
United States
Facility Name
Helen Keller Hospital
City
Sheffield
State/Province
Alabama
ZIP/Postal Code
25660
Country
United States
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Vertex Clinical Research
City
Bakersfield
State/Province
California
ZIP/Postal Code
CA
Country
United States
Facility Name
California Clinical Research
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
Facility Name
CORE Orthopedic Medical Center
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
JDP Medical
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80014
Country
United States
Facility Name
Southeastern Center for Clinical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30350
Country
United States
Facility Name
Chesapeake Research Group
City
Pasadena
State/Province
Maryland
ZIP/Postal Code
21122
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Allegehny Pain Management
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
University Orthopedics
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
Comprehensive Pain Specialists
City
Hendersonville
State/Province
Tennessee
ZIP/Postal Code
37075
Country
United States
Facility Name
Scott and White Memorial Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Jean Brown Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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