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

This study has been completed.
Information provided by:
Javelin Pharmaceuticals Identifier:
First received: July 23, 2007
Last updated: February 11, 2009
Last verified: January 2009
This study will compare repeated intermittent IV dosing of diclofenac in patient with moderate to severe post-surgical pain from elective orthopedic surgery.

Condition Intervention Phase
Postoperative Pain Drug: IV Diclofenac Drug: IV ketorolac Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Javelin Pharmaceuticals:

Primary Outcome Measures:
  • 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:
  • Other measures of pain relief [ Time Frame: Multiple ]

Enrollment: 277
Study Start Date: July 2007
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Placebo
Placebo q6h

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.

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00507026

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
Austin, Texas, United States, 78705
Sponsors and Collaborators
Javelin Pharmaceuticals
Study Director: Javelin Pharmaceuticals Javelin Pharmaceuticals
  More Information

Responsible Party: Javelin Pharmaceuticals Identifier: NCT00507026     History of Changes
Other Study ID Numbers: DFC-005
Study First Received: July 23, 2007
Last Updated: February 11, 2009

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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 processed this record on August 21, 2017