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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00709436
Recruitment Status : Completed
First Posted : July 3, 2008
Last Update Posted : January 11, 2012
Sponsor:
Information provided by (Responsible Party):
Hospira, now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE July 1, 2008
First Posted Date  ICMJE July 3, 2008
Last Update Posted Date January 11, 2012
Study Start Date  ICMJE June 2008
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2008)
Measures of pain intensity difference [ Time Frame: 0-6 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Repeated Doses of PMI-150 (Intranasal Ketamine) in Acute Post-operative Pain Following Orthopedic Surgery
Official Title  ICMJE 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: 1
    PMI-150 (intranasal ketamine) at time 0 and specified time points thereafter.
    Intervention: Drug: PMI-150 (intranasal ketamine)
  • Placebo Comparator: 2
    Placebo at time 0 and specified time points thereafter.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2009)
250
Original Estimated Enrollment  ICMJE
 (submitted: July 1, 2008)
220
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00709436
Other Study ID Numbers  ICMJE KET-017
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospira, now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Hospira, now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Javelin Pharmaceuticals Javelin Pharmaceuticals
PRS Account Hospira, now a wholly owned subsidiary of Pfizer
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP