An Open-Label Safety Study Of DIC075V (Intravenous Diclofenac Sodium) In Patients With Acute Post-Operative Pain
NCT ID: NCT00726388
Last Updated: 2021-10-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1050 participants
INTERVENTIONAL
2008-09-15
2009-05-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
IV administration of multiple doses of DIC075V (intravenous diclofenac sodium) over multiple days
DIC075V (intravenous diclofenac sodium)
multiple doses up to 5 days
Interventions
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DIC075V (intravenous diclofenac sodium)
multiple doses up to 5 days
Eligibility Criteria
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Inclusion Criteria
* Expected stay \> 48 hrs
Exclusion Criteria
* 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,
18 Years
85 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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West Alabama Research, LLC
Birmingham, Alabama, United States
Alabama Clinical Therapeutics
Birmingham, Alabama, United States
Shoals Clinical Research Associates, LLC, Eliza Coffee Memorial Hospital
Florence, Alabama, United States
Horizon Research Group
Mobile, Alabama, United States
Drug Research and Analysis Corp.
Montgomery, Alabama, United States
Jackson Hospital
Montgomery, Alabama, United States
Helen Keller Memorial Hospital
Sheffield, Alabama, United States
Pivotal Clinical Research
Peoria, Arizona, United States
Precision Trials
Phoenix, Arizona, United States
Teton Research, LLC
Little Rock, Arkansas, United States
Vertex
Bakersfield, California, United States
Lotus Clinical Research
Glendale, California, United States
Physicians Clinical Research
Laguna Hills, California, United States
National Institute of Clinical Research
Los Angeles, California, United States
Lotus Clinical Research
Pasadena, California, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, United States
North Coast Women's Care
Vista, California, United States
American Clinical Research
Aurora, Colorado, United States
Colorado Orthopedic Consultants
Englewood, Colorado, United States
American Clinical Research Services
Steamboat Springs, Colorado, United States
Orthopedic Associates of Hartford
Hartford, Connecticut, United States
Nature Coast Clinical Research
Inverness, Florida, United States
Sunrise Medical Research, Inc.
Lauderdale Lakes, Florida, United States
Pensacola Research Consultants
Pensacola, Florida, United States
Florida Orthopedic Institute
Tampa, Florida, United States
Soapstone Center for Clinical Research
Decatur, Georgia, United States
JRSI Foundation The center for Hip and Knee Surgery
Mooresville, Indiana, United States
University of Kansas Medical Center Department of Anesthesiology
Kansas City, Kansas, United States
Validity Research
Merriam, Kansas, United States
Tulane Univ. Medical Center
New Orleans, Louisiana, United States
Great Falls Clinic, LLP
Great Falls, Montana, United States
Albany Medical Center
Albany, New York, United States
Staten Island University Hospital
Staten Island, New York, United States
The Ohio State University Medical Center
Columbus, Ohio, United States
Allegheny Pain Management
Altoona, Pennsylvania, United States
University of Orthopedics Center
Altoona, Pennsylvania, United States
Ilumina Clinical Associates
Johnstown, Pennsylvania, United States
Ilumina Clinical Associates
Johnstown, Pennsylvania, United States
UPMC Presbyterian-Shadyshide Hospital
Pittsburgh, Pennsylvania, United States
UPMC-St. Margaret's Hospital
Pittsburgh, Pennsylvania, United States
Somerset Hospital
Somerset, Pennsylvania, United States
University Orthopedics Center
State College, Pennsylvania, United States
Comprehensive Pain Specialists, PLLC
Hendersonville, Tennessee, United States
Endeavor Clinical Trials
San Antonio, Texas, United States
Interventional Pain Management
San Antonio, Texas, United States
Scott & White Clinic / Texas A&M Health Science Center
Temple, Texas, United States
Countries
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References
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Chelly JE, Lacouture PG, Reyes CRD. Safety of Injectable HPbetaCD-Diclofenac in Older Patients with Acute Moderate-to-Severe Postoperative Pain: A Pooled Analysis of Three Phase III Trials. Drugs Aging. 2018 Mar;35(3):249-259. doi: 10.1007/s40266-018-0529-3.
Other Identifiers
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C1211011
Identifier Type: OTHER
Identifier Source: secondary_id
DFC-010
Identifier Type: -
Identifier Source: org_study_id