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

Completed · Phase 3

Conditions studied: Pain, Postoperative

In brief

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

Key facts

Study ID

NCT00726388

Run by

Pfizer

People needed

1050

Starts

2008-09-15

Expected to finish

2009-05-08

Last updated by the study team

2021-10-13

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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,

Where it is running

• 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

Full record on ClinicalTrials.gov

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