Efficacy and Safety of IV Diclofenac (DIC075V) for Pain After Abdominal or Pelvic Surgery
Information source: Javelin Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain, Postoperative
Intervention: Intravenous Diclofenac (DIC075V) (Drug); Parenteral Ketorolac (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Javelin Pharmaceuticals
Summary
This study will compare repeated intermittent IV dosing of diclofenac in patients with
moderate to severe post-surgical pain from abdominal or pelvic surgery. The primary objective
is to evaluate the efficacy and safety of two dosage levels of parenteral diclofenac in
providing pain relief as compared to placebo or Ketorolac tromethamine.
Clinical Details
Official title: Randomized, Double-Blind, Active- and Placebo-Controlled Study of the Efficacy and Safety of Repeated Dosing of DIC075V Relative To Parenteral Ketorolac and Placebo in Patients With Acute Post-Op Pain After Abdominal or Pelvic Surgery
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Sum of the pain intensity differences (SPID) over the 0-48 hour time interval.
Secondary outcome: SPID over the 0-24 hour intervalOther measures of pain relief
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Scheduled within two weeks of the screening visit to undergo abdominal or pelvic
surgery
- Moderate to severe pain within 6 hours following completion of the required surgery.
Exclusion Criteria:
- Surgical procedure involves a subcostal incision.
- Chronic disease or recent cardiovascular events.
- Known allergy or hypersensitivity to the active compounds or any of the excipients
used in the study.
Additional Inclusion/Exclusion Criteria May Apply
Locations and Contacts
Alabama Clinical Therapeutics, Birmingham, Alabama 35235, United States
Helen Keller Hospital, Sheffield, Alabama 35660, United States
Drug Research and Analysis Corp., Montgomery, Alabama 36106, United States
Eliza Coffee Memorial Hospital, Florence, Alabama 35630, United States
Teton Research / Parkview Surgical, Little Rock, Arkansas 72205, United States
Glendale Adventist Medical Center, Glendale, California 91206, United States
Saddleback Memorial Medical Center, Laguna Hills, California 92653, United States
Clinical Management Services, Arcadia, California 91107, United States
Visions Clinical Research, Boynton Beach, Florida 33437, United States
Duke University Medical Center, Durham, North Carolina 27710, United States
Clinical Research Services, Bismarck, North Dakota 58501, United States
Clinical Research Center, Austin, Texas 78705, United States
Clinical Research Center, San Marcos, Texas 78666, United States
The Woman's Hospital of Texas, Houston, Texas 77054, United States
Memorial Hermann Healthcare System - Memorial City Hospital, Houston, Texas 77024, United States
Jean Brown Research, Salt Lake City, Utah 84124, United States
Additional Information
Starting date: May 2006
Ending date: June 2007
Last updated: July 23, 2007
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