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

• Status: Completed
• Trial end date: 2009-05-08
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Javelin Pharmaceuticals; Pfizer
• Treatments: Diclofenac

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,