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

Summary

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

Timeline

Start

2006-05

Primary completion

2007-11

Completion

2007-11

Outcome

Met primary endpoint

paper Over the first 48 hours, both IV HPβCD diclofenac doses, as well as ketorolac, produced significant reductions in pain intensity over placebo (all P < 0.05), PMID 22886837 ↗

Publications

• Chelly JE, Lacouture PG, Reyes CRD. Safety of Injectable HPbetaCD-Diclofenac in Older Patients with Acute Moderate-to-Severe Postoperative Pain: A Pooled Analysis of Three Phase III Trials. Drugs Aging. 2018 Mar;35(3):249-259. doi: 10.1007/s40266-018-0529-3.
• Gan TJ, Daniels SE, Singla N, Hamilton DA, Carr DB. A novel injectable formulation of diclofenac compared with intravenous ketorolac or placebo for acute moderate-to-severe pain after abdominal or pelvic surgery: a multicenter, double-blind, randomized, multiple-dose study. Anesth Analg. 2012 Nov;115(5):1212-20. doi: 10.1213/ANE.0b013e3182691bf9. Epub 2012 Aug 10.

Drugs

Indications