Efficacy and Safety of IV Diclofenac (DIC075V) for Pain After Abdominal or Pelvic Surgery - Full Text View

Sponsored by:	Javelin Pharmaceuticals
Information provided by:	Javelin Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00448110

Purpose

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.

Condition	Intervention	Phase
Pain, Postoperative	Drug: Intravenous Diclofenac (DIC075V) Drug: Parenteral Ketorolac	Phase III

Drug Information available for: Ketorolac Ketorolac tromethamine Diclofenac Diclofenac potassium Diclofenac sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Javelin Pharmaceuticals:

Primary Outcome Measures:

Sum of the pain intensity differences (SPID) over the 0-48 hour time interval.

Secondary Outcome Measures:

SPID over the 0-24 hour interval
Other measures of pain relief

Estimated Enrollment:	320
Study Start Date:	May 2006
Study Completion Date:	June 2007

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00448110

Locations

United States, Alabama
Alabama Clinical Therapeutics
Birmingham, Alabama, United States, 35235
Helen Keller Hospital
Sheffield, Alabama, United States, 35660
Drug Research and Analysis Corp.
Montgomery, Alabama, United States, 36106
Eliza Coffee Memorial Hospital
Florence, Alabama, United States, 35630
United States, Arkansas
Teton Research / Parkview Surgical
Little Rock, Arkansas, United States, 72205
United States, California
Glendale Adventist Medical Center
Glendale, California, United States, 91206
Saddleback Memorial Medical Center
Laguna Hills, California, United States, 92653
Clinical Management Services
Arcadia, California, United States, 91107
United States, Florida
Visions Clinical Research
Boynton Beach, Florida, United States, 33437
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, North Dakota
Clinical Research Services
Bismarck, North Dakota, United States, 58501
United States, Texas
Clinical Research Center
Austin, Texas, United States, 78705
Clinical Research Center
San Marcos, Texas, United States, 78666
The Woman's Hospital of Texas
Houston, Texas, United States, 77054
Memorial Hermann Healthcare System - Memorial City Hospital
Houston, Texas, United States, 77024
United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124

Sponsors and Collaborators

Javelin Pharmaceuticals

More Information

Study ID Numbers:	DFC-004
Study First Received:	March 13, 2007
Last Updated:	July 23, 2007
ClinicalTrials.gov Identifier:	NCT00448110
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Postoperative Complications
Ketorolac
Diclofenac

Pain
Ketorolac Tromethamine
Pain, Postoperative

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Pathologic Processes
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009