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

Last updated: September 29, 2021
Sponsor: Pfizer
Overall Status: Completed

Phase

3

Condition

Pain

Chronic Pain

Post-surgical Pain

Treatment

N/A

Clinical Study ID

NCT00507026
DFC-005
C1211009
  • Ages 18-85
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 277
Study Start date:
July 25, 2007
Estimated Completion Date:
October 14, 2008

Study 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.

Connect with a study center

  • Helen Keller Hospital

    Sheffield, Alabama 35660
    United States

    Site Not Available

  • Arizona Research Center

    Phoenix, Arizona 85023
    United States

    Site Not Available

  • Accurate Clinical Trials

    San Clemente, California 92672
    United States

    Site Not Available

  • East Coast Clincial Research

    Fort Pierce, Florida 34950
    United States

    Site Not Available

  • East Coast Clincial Research

    Ft. Pierce, Florida 34950
    United States

    Site Not Available

  • Outcomes Research Institute

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • American Institute of Healthcare and Fitness

    Raleigh, North Carolina 27615
    United States

    Site Not Available

  • University Orthopedics Center

    State College, Pennsylvania 16081
    United States

    Site Not Available

  • SCIREX

    Austin, Texas 78705
    United States

    Site Not Available

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