Efficacy and Safety of IV Diclofenac (DIV075V)for Pain After Elective Orthopedic Surgery

Randomized, Double-Blind, Active-and Placebo-Controlled Study of the Analgesic Efficacy and Safety of Repeated Dosing of DIC075V Versus Parenteral Ketorolac and Placebo in Acute Post-Operative Pain After Elective Orthopedic Surgery

This study will compare repeated intermittent IV dosing of diclofenac in patient with moderate to severe post-surgical pain from elective orthopedic surgery.

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

Inclusion Criteria:

• Scheduled within three weeks of the screening visit to undergo elective orthopedic surgery.
• Moderate to severe pain within 6 hours following completion of the required surgery.

Exclusion Criteria:

• Chronic pain conditions.
• Chronic disease or recent cardiovascular events.
• Known allergy or hypersensitivity to the active compounds or any of the excipients used in the study.