This study will compare repeated intermittent IV dosing of diclofenac in patient with moderate to severe post-surgical pain from elective orthopedic surgery...
Date First Received: July 23, 2007
Last Updated: January 11, 2008
Verified by: Javelin Pharmaceuticals, January 2008
Clinical Trial Phase: Phase 3 | Start Date: July 2007
Overall Status: Recruiting
Estimated Enrollment: 240
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
This study will compare repeated intermittent IV dosing of diclofenac in patient with moderate to severe post-surgical pain from elective orthopedic surgery.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Detailed Clinical Trial 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.
Outcome Measures for this Clinical Trial
Primary:
- Sum of the pain intensity differences (SPID) over 0-24, 0-48, 0-72, 0-96 and 0-120 hour time intervals. Multiple No
Secondary:
- Other measures of pain relief Multiple No
Criteria for Participation in this Clinical Trial
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.
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: Javelin Pharmaceuticals
Helen Keller Hospital
Sheffield Alabama 35660 United States
Arizona Research Center
Phoenix Arizona 85023 United States
Accurate Clinical Trials
San Clemente California 92672 United States
East Coast Clincial Research
Ft. Pierce Florida 34950 United States
Outcomes Research Institute
Louisville Kentucky 40202 United States
American Institute of Healthcare and Fitness
Raleigh North Carolina 27615 United States
University Orthopedics Center
State College Pennsylvania 16081 United States
SCIREX
Austin Texas 78705 United States
Overall Clinical Trial Officials and Contacts
Javelin Pharmaceuticals Study Director Javelin Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on July 18, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00507026
Study ID Number: DFC-005
ClinicalTrials.gov Identifier: NCT00507026
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
