NCT00448110

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 331 (actual)
• Sponsor: Javelin Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Intravenous Diclofenac (DIC075V)	Intravenous Diclofenac (DIC075V): 1 of 2 dosage levels
DRUG	Intravenous Ketorolac	Intravenous Ketorolac
DRUG	placebo	placebo

Timeline

• Start date: 2006-05-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2007-03-15
• Last updated: 2009-05-22

Locations

14 sites across 1 country: United States