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Efficacy and Safety of IV Diclofenac (DIV075V)for Pain After Elective Orthopedic Surgery

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ClinicalTrials.gov Identifier: NCT00507026
Recruitment Status : Completed
First Posted : July 25, 2007
Last Update Posted : February 12, 2009
Sponsor:
Information provided by:
Javelin Pharmaceuticals

Brief Summary:
This study will compare repeated intermittent IV dosing of diclofenac in patient with moderate to severe post-surgical pain from elective orthopedic surgery.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: IV Diclofenac Drug: IV ketorolac Drug: Placebo Phase 3

Detailed Description:
The primary objective is to evaluate the analgesic efficacy and safety of three dosage levels of parenteral diclofenac in providing pain relief as compared to placebo or Ketorolac tromethamine.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 277 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Active-and Placebo-Controlled Study of the Analgesic Efficacy and Safety of Repeated Dosing of DIC075V Versus Parenteral Ketorolac and Placebo in Acute Post-Operative Pain After Elective Orthopedic Surgery
Study Start Date : July 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
DIC075V (IV diclofenac)
Drug: IV Diclofenac
IV Diclofenac q6h
Active Comparator: B
IV Ketorolac
Drug: IV ketorolac
IV ketorolac q6h
Placebo Comparator: C
Placebo
Drug: Placebo
Placebo q6h



Primary Outcome Measures :
  1. Sum of the pain intensity differences (SPID) over 0-24, 0-48, 0-72, 0-96 and 0-120 hour time intervals. [ Time Frame: Multiple ]

Secondary Outcome Measures :
  1. Other measures of pain relief [ Time Frame: Multiple ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled within three weeks of the screening visit to undergo elective orthopedic surgery.
  • Moderate to severe pain within 6 hours following completion of the required surgery.

Exclusion Criteria:

  • Chronic pain conditions.
  • Chronic disease or recent cardiovascular events.
  • Known allergy or hypersensitivity to the active compounds or any of the excipients used in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00507026


Locations
United States, Alabama
Helen Keller Hospital
Sheffield, Alabama, United States, 35660
United States, Arizona
Arizona Research Center
Phoenix, Arizona, United States, 85023
United States, California
Accurate Clinical Trials
San Clemente, California, United States, 92672
United States, Florida
East Coast Clincial Research
Ft. Pierce, Florida, United States, 34950
United States, Kentucky
Outcomes Research Institute
Louisville, Kentucky, United States, 40202
United States, North Carolina
American Institute of Healthcare and Fitness
Raleigh, North Carolina, United States, 27615
United States, Pennsylvania
University Orthopedics Center
State College, Pennsylvania, United States, 16081
United States, Texas
SCIREX
Austin, Texas, United States, 78705
Sponsors and Collaborators
Javelin Pharmaceuticals
Investigators
Study Director: Javelin Pharmaceuticals Javelin Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Javelin Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00507026     History of Changes
Other Study ID Numbers: DFC-005
First Posted: July 25, 2007    Key Record Dates
Last Update Posted: February 12, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Diclofenac
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action