Status:
COMPLETED
An Open-Label Safety Study Of DIC075V (Intravenous Diclofenac Sodium) In Patients With Acute Post-Operative Pain
Lead Sponsor:
Pfizer
Conditions:
Pain, Postoperative
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
This is an open-label, multiple-dose, safety study of DIC075V in patients with acute post-operative pain following abdominal or orthopedic surgery.
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 ...
Eligibility Criteria
Inclusion
- 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
- 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,
Key Trial Info
Start Date :
September 15 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 8 2009
Estimated Enrollment :
1050 Patients enrolled
Trial Details
Trial ID
NCT00726388
Start Date
September 15 2008
End Date
May 8 2009
Last Update
October 13 2021
Active Locations (46)
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1
West Alabama Research, LLC
Birmingham, Alabama, United States, 35209
2
Alabama Clinical Therapeutics
Birmingham, Alabama, United States, 35235
3
Shoals Clinical Research Associates, LLC, Eliza Coffee Memorial Hospital
Florence, Alabama, United States, 35630
4
Horizon Research Group
Mobile, Alabama, United States, 36608