An Open-Label Safety Study Of DIC075V (Intravenous Diclofenac Sodium) In Patients With Acute Post-Operative Pain - Full Text View

Purpose

This is an open-label, multiple-dose, safety study of DIC075V in patients with acute post-operative pain following abdominal or orthopedic surgery.

Condition	Intervention	Phase
Pain, Postoperative	Drug: DIC075V (intravenous diclofenac sodium)	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label, Multiple-Dose, Multiple-Day, Non-Randomized, Single-Arm Safety Study Of Repeat-Doses Of DIC075V (Intravenous Diclofenac Sodium) In Patients With Acute Post-Operative Pain

Resource links provided by NLM:

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac

U.S. FDA Resources

Further study details as provided by Javelin Pharmaceuticals:

Primary Outcome Measures:

Adverse Events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	850
Study Start Date:	September 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A IV administration of multiple doses of DIC075V (intravenous diclofenac sodium) over multiple days	Drug: DIC075V (intravenous diclofenac sodium) multiple doses up to 5 days

Detailed Description:

This is an open-label, multiple-dose, multiple-day, single-arm safety study of repeat-doses of DIC075V in patients with acute post-operative pain following abdominal (i.e., non-laparoscopic abdominal surgeries) or orthopedic (e.g., hip or knee joint replacement) surgery. Eligible patients will receive DIC075V IV bolus q6 hours. Safety assessments will be collected at baseline (immediately prior to starting DIC075V therapy) and at study discharge or early termination.

Eligibility

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

Criteria

Inclusion Criteria:

abdominal ( non-laparoscopic abdominal surgeries) or orthopedic ( hip or knee joint replacement) surgery or other surgeries requiring multiple doses of parenterally administered NSAIDs over multiple days
Expected stay > 48 hrs

Exclusion Criteria:

bilirubin > 2.5 mg/dl
prothrombin time is > 20% above the upper limit of normal
serum creatinine is > 1.9 mg/dl at screening.
known allergy or hypersensitivity to diclofenac, other NSAIDs,

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726388

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Locations

United States, Alabama
West Alabama Research, LLC
Birmingham, Alabama, United States, 35209
Alabama Clinical Therapeutics
Birmingham, Alabama, United States, 35235
Shoals Clinical Research Associates, LLC, Eliza Coffee Memorial Hospital
Florence, Alabama, United States, 35630
Horizon Research Group
Mobile, Alabama, United States, 36608
Drug Research and Analysis Corp.
Montgomery, Alabama, United States, 36106
Jackson Hospital
Montgomery, Alabama, United States, 36106
Helen Keller Memorial Hospital
Sheffield, Alabama, United States, 35660
United States, Arizona
Pivotal Clinical Research
Peoria, Arizona, United States, 85381
Precision Trials
Phoenix, Arizona, United States, 85032
United States, Arkansas
Teton Research, LLC
Little Rock, Arkansas, United States, 72205
United States, California
Vertex
Bakersfield, California, United States, 93311
Lotus Clinical Research
Glendale, California, United States, 91206
Physicians Clinical Research
Laguna HIlls, California, United States, 92653
National Institute of Clinical Research
Los Angeles, California, United States, 90017
Lotus Clinical Research
Pasadena, California, United States, 91105
Santa Barbara Cottage Hospital
Santa Barbara, California, United States, 93105
North Coast Women's Care
Vista, California, United States, 92083
United States, Colorado
American Clinical Research
Aurora, Colorado, United States
Colorado Orthopedic Consultants
Englewood, Colorado, United States, 80110
American Clinical Research Services
Steamboat Springs, Colorado, United States, 80487
United States, Connecticut
Orthopedic Associates of Hartford
Hartford, Connecticut, United States, 06106
United States, Florida
Nature Coast Clinical Research
Inverness, Florida, United States, 34452
Sunrise Medical Research, Inc.
Lauderdale Lakes, Florida, United States
Pensacola Research Consultants
Pensacola, Florida, United States, 32504
Florida Orthopedic Institute
Tampa, Florida, United States, 33637
United States, Georgia
Soapstone Center for Clinical Research
Decatur, Georgia, United States, 33034
United States, Indiana
JRSI Foundation The center for Hip and Knee Surgery
Mooresville, Indiana, United States, 46158
United States, Kansas
University of Kansas Medical Center Department of Anesthesiology
Kansas City, Kansas, United States, 66160
Validity Research
Merriam, Kansas, United States, 66204
United States, Louisiana
Tulane Univ. Medical Center
New Orleans, Louisiana, United States, 70113
United States, Montana
Great Falls Clinic, LLP
Great Falls, Montana, United States, 59405
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
Staten Island University Hospital
Staten Island, New York, United States, 10305
United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Orthopedics Center
Altoona, Pennsylvania, United States, 16602
Allegheny Pain Management
Altoona, Pennsylvania, United States, 16602
Ilumina Clinical Associates
Johnstown, Pennsylvania, United States, 15904
Ilumina Clinical Associates
Johnstown, Pennsylvania, United States, 15504
UPMC-St. Margaret's Hospital
Pittsburg, Pennsylvania, United States, 15232
UPMC Presbyterian-Shadyshide Hospital
Pittsburg, Pennsylvania, United States, 15232
Somerset Hospital
Somerset, Pennsylvania, United States, 15501
University Orthopedics Center
State College, Pennsylvania, United States, 16801
United States, Tennessee
Comprehensive Pain Specialists, PLLC
Hendersonville, Tennessee, United States, 37075
United States, Texas
Endeavor Clinical Trials
San Antonio, Texas, United States, 78229
Interventional Pain Management
San Antonio, Texas, United States, 78258
Scott & White Clinic / Texas A&M Health Science Center
Temple, Texas, United States, 76508

Sponsors and Collaborators

Javelin Pharmaceuticals

Investigators

Study Director:

Javelin Pharmaceuticals

More Information

No publications provided

Responsible Party:	Javelin Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00726388 History of Changes
Other Study ID Numbers:	DFC-010
Study First Received:	July 29, 2008
Last Updated:	April 17, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Javelin Pharmaceuticals:

safety
diclofenac
pain, postoperative

Additional relevant MeSH terms:

Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Diclofenac
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 May 22, 2013