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

PHASE3CompletedINTERVENTIONAL
Enrollment

319

Participants

Timeline

Start Date

January 31, 2005

Primary Completion Date

January 31, 2008

Study Completion Date

January 31, 2008

Conditions
Pain
Interventions
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)"

Trial Locations (13)

5000

Royal Adelaide Hospital, Adelaide

35233

Cooper Green Hospital / Jefferson Clinic, Birmingham

35235

Medical Center East / Alabama Clinical Therapeutics, Birmingham

36106

Jackson Hospital / Drug Research and Analysis Corporation, Montgomery

36111

Baptist Medical Center South / Drug Research and Analysis Corporation, Montgomery

36608

Springhill Hospital / Wilmax Clinical Research, Inc., Mobile

37075

Comprehensive Pain Specialists, Hendersonville

40536

Chandler Medical Center; Ken Muse Research, Lexington

67208

Research Support Personnel LLC, Wichita

76135

Health First Medical Group, Fort Worth

85023

Arizona Research Center, Phoenix

92324

Valley OB/GYN, Colton

36652-2144

Mobile Infirmary Medical Center / Wilmax Clinical Research, Inc., Mobile

Sponsors
All Listed Sponsors
lead

Cumberland Pharmaceuticals

INDUSTRY