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

Sponsor:	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.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:

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

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

SPID over the 0-24 hour interval [ Time Frame: 0-24 hours ] [ Designated as safety issue: No ]
Other measures of pain relief [ Time Frame: Multiple ] [ Designated as safety issue: No ]

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 placebo	Drug: placebo 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.

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
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

More Information

No publications provided

Responsible Party:	Javelin Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00448110 History of Changes
Other Study ID Numbers:	DFC-004
Study First Received:	March 13, 2007
Last Updated:	May 21, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012