Efficacy and Safety of IV Diclofenac (DIV075V)for Pain After Elective Orthopedic Surgery - Full Text View

Sponsor:	Javelin Pharmaceuticals
Information provided by:	Javelin Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00507026

Purpose

This study will compare repeated intermittent IV dosing of diclofenac in patient with moderate to severe post-surgical pain from elective orthopedic surgery.

Condition	Intervention	Phase
Postoperative Pain	Drug: IV Diclofenac Drug: IV 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 Analgesic Efficacy and Safety of Repeated Dosing of DIC075V Versus Parenteral Ketorolac and Placebo in Acute Post-Operative Pain After Elective Orthopedic 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 0-24, 0-48, 0-72, 0-96 and 0-120 hour time intervals. [ Time Frame: Multiple ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Other measures of pain relief [ Time Frame: Multiple ] [ Designated as safety issue: No ]

Enrollment:	277
Study Start Date:	July 2007
Study Completion Date:	January 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A DIC075V (IV diclofenac)	Drug: IV Diclofenac IV Diclofenac q6h
Active Comparator: B IV Ketorolac	Drug: IV ketorolac IV ketorolac q6h
Placebo Comparator: C Placebo	Drug: Placebo Placebo q6h

Detailed Description:

The primary objective is to evaluate the analgesic efficacy and safety of three dosage levels of parenteral diclofenac in providing pain relief as compared to placebo or Ketorolac tromethamine.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Scheduled within three weeks of the screening visit to undergo elective orthopedic surgery.
Moderate to severe pain within 6 hours following completion of the required surgery.

Exclusion Criteria:

Chronic pain conditions.
Chronic disease or recent cardiovascular events.
Known allergy or hypersensitivity to the active compounds or any of the excipients used in the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507026

Locations

United States, Alabama
Helen Keller Hospital
Sheffield, Alabama, United States, 35660
United States, Arizona
Arizona Research Center
Phoenix, Arizona, United States, 85023
United States, California
Accurate Clinical Trials
San Clemente, California, United States, 92672
United States, Florida
East Coast Clincial Research
Ft. Pierce, Florida, United States, 34950
United States, Kentucky
Outcomes Research Institute
Louisville, Kentucky, United States, 40202
United States, North Carolina
American Institute of Healthcare and Fitness
Raleigh, North Carolina, United States, 27615
United States, Pennsylvania
University Orthopedics Center
State College, Pennsylvania, United States, 16081
United States, Texas
SCIREX
Austin, Texas, United States, 78705

Sponsors and Collaborators

Javelin Pharmaceuticals

Investigators

Study Director:

Javelin Pharmaceuticals

More Information

No publications provided

Responsible Party:	Javelin Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00507026 History of Changes
Other Study ID Numbers:	DFC-005
Study First Received:	July 23, 2007
Last Updated:	February 11, 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