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

This study has been completed.
Information provided by:
Javelin Pharmaceuticals Identifier:
First received: March 13, 2007
Last updated: May 21, 2009
Last verified: May 2009
This study will compare repeated intermittent IV dosing of diclofenac in patients with moderate to severe post-surgical pain from abdominal or pelvic surgery.

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

Resource links provided by NLM:

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. [ Time Frame: 0-48 hours ]

Secondary Outcome Measures:
  • SPID over the 0-24 hour interval [ Time Frame: 0-24 hours ]
  • Other measures of pain relief [ Time Frame: Multiple ]

Enrollment: 331
Study Start Date: May 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
intravenous diclofenac dosage level 1
Drug: Intravenous Diclofenac (DIC075V)
Intravenous Diclofenac (DIC075V): 1 of 2 dosage levels
Experimental: B
intravenous diclofenac dosage level 2
Drug: Intravenous Diclofenac (DIC075V)
Intravenous Diclofenac (DIC075V): 1 of 2 dosage levels
Active Comparator: C
intravenous ketorolac
Drug: Intravenous Ketorolac
Intravenous Ketorolac
Placebo Comparator: D
Drug: placebo

Detailed Description:
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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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: NCT00448110

United States, Alabama
Alabama Clinical Therapeutics
Birmingham, Alabama, United States, 35235
Eliza Coffee Memorial Hospital
Florence, Alabama, United States, 35630
Drug Research and Analysis Corp.
Montgomery, Alabama, United States, 36106
Helen Keller Hospital
Sheffield, Alabama, United States, 35660
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
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
Memorial Hermann Healthcare System - Memorial City Hospital
Houston, Texas, United States, 77024
Clinical Research Center
San Marcos, Texas, United States, 78666
United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Javelin Pharmaceuticals
Study Director: Javelin Pharmaceuticals Javelin Pharmaceuticals
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Javelin Pharmaceuticals Identifier: NCT00448110     History of Changes
Other Study ID Numbers: DFC-004
Study First Received: March 13, 2007
Last Updated: May 21, 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 18, 2017