NCT00225732

Trial of Caldolor for Treatment of Pain in Post-Operative Adult Patients

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial of Ibuprofen Injection (IVIb) for Treatment of Pain in the Post-Operative Adult Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 319 (actual)
• Sponsor: Cumberland Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study of Caldolor (IV ibuprofen) administered to post-operative hospitalized adult patients every 6 hours for 48 hours is to determine the efficacy of Caldolor compared to placebo for the treatment of post-operative pain as measured by reduction in the requirement for the narcotic analgesic, morphine, post surgery

Conditions

• Pain

Interventions

Type	Name	Description
OTHER	Normal saline as placebo comparator	250 ml normal saline as a placebo comparator was administered every 6 hours for a total of eight doses over the first 48 hours. Those patients who received the initial eight doses could continue to receive additional doses as needed through the end of the treatment period (day 5)
DRUG	Intravenous ibuprofen	800 mg intravenous ibuprofen diluted in 250 milliliters of normal saline was administered every 6 hours for a total of eight doses over the first 48 hours. Those patients who received the initial eight doses could continue to receive additional doses as needed through the end of the treatment period (day 5)

Timeline

• Start date: 2005-01-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2005-09-26
• Last updated: 2016-06-22
• Results posted: 2011-09-15

Locations

13 sites across 2 countries: United States, Australia