Conditions: Pain, Postoperative
Keywords: safety diclofenac pain, postoperative
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 1050
Healthy volunteers: no

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 surgeries) or orthopedic (e.g., hip or knee joint replacement) surgery. Eligible patients will receive DIC075V IV bolus q6 hours. Safety assessments will be collected at baseline (immediately prior to starting DIC075V therapy) and at study discharge or early termination.

Arms:
arm 1: IV administration of multiple doses of DIC075V (intravenous diclofenac sodium) over multiple days

Interventions: intervention 1: DIC075V (intravenous diclofenac sodium)
Intervention descriptions: intervention 1: multiple doses up to 5 days

Protocol document: