Efficacy and Safety of IV Diclofenac (DIV075V)for Pain After Elective Orthopedic Surgery
Information source: Javelin Pharmaceuticals
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Pain
Intervention: IV Diclofenac (Drug); IV ketorolac (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Javelin Pharmaceuticals Official(s) and/or principal investigator(s):
Javelin Pharmaceuticals, Study Director, Affiliation: Javelin Pharmaceuticals
Summary
This study will compare repeated intermittent IV dosing of diclofenac in patient with
moderate to severe post-surgical pain from elective orthopedic surgery.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Sum of the pain intensity differences (SPID) over 0-24, 0-48, 0-72, 0-96 and 0-120 hour time intervals.
Secondary outcome: Other measures of pain relief
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
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.
Locations and Contacts
Helen Keller Hospital, Sheffield, Alabama 35660, United States; Recruiting
Peg Pennington, Phone: 256-386-4001
Arizona Research Center, Phoenix, Arizona 85023, United States; Recruiting
Wendy Lee, Phone: 602-863-6363
Accurate Clinical Trials, San Clemente, California 92672, United States; Recruiting
Sara Love, Phone: 949-305-7008
East Coast Clincial Research, Ft. Pierce, Florida 34950, United States; Recruiting
Marianne Bridges, Phone: 321-574-0441
Outcomes Research Institute, Louisville, Kentucky 40202, United States; Recruiting
Diane DeLong, Phone: 502-852-2604
American Institute of Healthcare and Fitness, Raleigh, North Carolina 27615, United States; Withdrawn
University Orthopedics Center, State College, Pennsylvania 16081, United States; Recruiting
Sue Jepson, Phone: 814-231-2101
SCIREX, Austin, Texas 78705, United States; Recruiting
Alicia Bauman, Phone: 512-320-1600
Additional Information
Starting date: July 2007
Ending date: June 2008
Last updated: January 11, 2008
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