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

Phase 3

Completed

• Conditions: Pain
• Interventions: Drug: Intravenous ibuprofen; Other: Normal saline as placebo comparator

• Registration Number: NCT00225732
• Lead Sponsor: Cumberland Pharmaceuticals

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-09-22
• Study First Submitted QC: 2005-09-22
• Study First Posted: 2005-09-26
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Results First Submitted: 2011-04-01
• Results First Submitted QC: 2011-08-10
• Results First Posted: 2011-09-15
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-17
• Last Update Posted: 2016-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 319

Inclusion Criteria

1. Scheduled for elective abdominal hysterectomy surgery with anticipated need for post-operative I.V. morphine analgesia with anticipated use of ≥ 24 hours.
2. Adequate IV access
3. Anticipated hospital stay ≥ 24 hours

Exclusion Criteria

1. Be unable to make a reliable self-report of pain intensity to pain relief
2. Less than 18 years of age
3. Greater than 70 years of age
4. Use of NSAIDs within 12 hours prior to dosing
5. Use of analgesics, muscle relaxants and sedatives less than 24 hours prior to CTM administration with the following exceptions: paracetamol (acetaminophen) can be administered until 6 hours prior to surgery; tramadol can be administered until midnight the evening prior to surgery; muscle relaxants working at the neuromuscular junction used for intubation and/or anesthesia administration for the surgical procedure prior to CTM administration; and sedatives (i.e., midazolam) used as a co-induction agent for the surgical procedure prior to CTM administration
6. Patients taking warfarin, lithium, combination of ACE-inhibitors and furosemide
7. Patients with anemia (active clinically significant) and/or a history or evidence of asthma or heart failure
8. History of allergy or hypersensitivity to any component of Caldolor, aspirin (or aspirin related products), NSAIDs, or COX-2 inhibitors
9. Pregnant or nursing
10. History of severe head trauma that required current hospitalization, intracranial surgery or stroke within the previous 30 days, or any history of intracerebral arteriovenous malformation, cerebral aneurysm or CNS mass lesion
11. Weigh less than 30kg
12. Have a history of congenital bleeding diathesis (eg hemophilia) or any active clinically significant bleeding, or have underlying platelet dysfunction including (but not limited to) idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, or congenital platelet dysfunction
13. Have GI bleeding that required medical intervention within the previous 6 weeks (unless definitive surgery has been performed)
14. Have a platelet count less than 30,000mm3 determined within the 28 days prior to surgery
15. Pre-existing dependence on narcotics or known tolerance to opioids
16. Inability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]), and agree to abide by the study restrictions and to return for the required assessments
17. Refusal to provide written authorization for use and disclosure of protected health information
18. Be on dialysis, have oliguria or calculated creatinine clearance of less than 60 mL/min (calculated using the Cockcroft and Gault formula) determined within the 28 days prior to surgery
19. Inability to achieve hemostasis or inability to close surgical incision, prior to Operating Room discharge
20. Operative procedure includes organ transplant
21. Pre or intra-operative procedure utilized for the prevention of pre- or post-operative pain (i.e. epidural or nerve blocks)
22. Be receiving full dose anticoagulation therapy or Activated Protein C within 6 hours before dosing (Prophylaxis with subcutaneous heparin is acceptable)
23. Have received another investigational drug within the past 30 days
24. Be otherwise unsuitable for the study in the opinion of the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intravenous ibuprofen	Intravenous ibuprofen	-
normal saline	Normal saline as placebo comparator	-

Primary Outcome Measures

Name	Time	Method
Change in the Patient Demand for the Narcotic Analgesic, Morphine, Post Surgery	24 Hours	Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 24 hour period post-surgery

Trial Locations

Locations (13)

Medical Center East / Alabama Clinical Therapeutics; 🇺🇸 Birmingham, Alabama, United States

Mobile Infirmary Medical Center / Wilmax Clinical Research, Inc.; 🇺🇸 Mobile, Alabama, United States

Jackson Hospital / Drug Research and Analysis Corporation; 🇺🇸 Montgomery, Alabama, United States

Valley OB/GYN; 🇺🇸 Colton, California, United States

Chandler Medical Center; Ken Muse Research; 🇺🇸 Lexington, Kentucky, United States

Health First Medical Group; 🇺🇸 Fort Worth, Texas, United States

Royal Adelaide Hospital; 🇦🇺 Adelaide, Australia

Research Support Personnel LLC; 🇺🇸 Wichita, Kansas, United States

Arizona Research Center; 🇺🇸 Phoenix, Arizona, United States

Comprehensive Pain Specialists; 🇺🇸 Hendersonville, Tennessee, United States

Baptist Medical Center South / Drug Research and Analysis Corporation; 🇺🇸 Montgomery, Alabama, United States

Springhill Hospital / Wilmax Clinical Research, Inc.; 🇺🇸 Mobile, Alabama, United States

Cooper Green Hospital / Jefferson Clinic; 🇺🇸 Birmingham, Alabama, United States