Efficacy and Safety of IV Diclofenac (DIC075V) for Pain After Abdominal or Pelvic Surgery

Randomized, Double-Blind, Active- and Placebo-Controlled Study of the Efficacy and Safety of Repeated Dosing of DIC075V Relative To Parenteral Ketorolac and Placebo in Patients With Acute Post-Op Pain After Abdominal or Pelvic Surgery

This study will compare repeated intermittent IV dosing of diclofenac in patients with moderate to severe post-surgical pain from abdominal or pelvic surgery.

The primary objective is to evaluate the efficacy and safety of two dosage levels of parenteral diclofenac in providing pain relief as compared to placebo or Ketorolac tromethamine.

Inclusion Criteria:

• Scheduled within two weeks of the screening visit to undergo abdominal or pelvic surgery
• Moderate to severe pain within 6 hours following completion of the required surgery.

Exclusion Criteria:

• Surgical procedure involves a subcostal incision.
• Chronic disease or recent cardiovascular events.
• Known allergy or hypersensitivity to the active compounds or any of the excipients used in the study.

Additional Inclusion/Exclusion Criteria May Apply