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

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ClinicalTrials.gov Identifier: NCT00448110
Recruitment Status : Completed
First Posted : March 15, 2007
Last Update Posted : May 22, 2009
Sponsor:
Information provided by:
Javelin Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Intravenous Diclofenac (DIC075V) Drug: Intravenous Ketorolac Drug: placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 331 participants
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
Study Start Date : May 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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
placebo
Drug: placebo
placebo



Primary Outcome Measures :
  1. Sum of the pain intensity differences (SPID) over the 0-48 hour time interval. [ Time Frame: 0-48 hours ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00448110


Locations
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
Investigators
Study Director: Javelin Pharmaceuticals Javelin Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Javelin Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00448110     History of Changes
Other Study ID Numbers: DFC-004
First Posted: March 15, 2007    Key Record Dates
Last Update Posted: May 22, 2009
Last Verified: May 2009

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Diclofenac
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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