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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00225732
• Other study ID #: CPI-CL-008
• Status: Completed
• Phase: Phase 3
• First received: September 22, 2005
• Last updated: August 10, 2011
• Start date: January 2005
• Est. completion date: January 2008

Study information

• Verified date: August 2011
• Source: Cumberland Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 319
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

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)

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide
United States	Cooper Green Hospital / Jefferson Clinic	Birmingham	Alabama
United States	Medical Center East / Alabama Clinical Therapeutics	Birmingham	Alabama
United States	Valley OB/GYN	Colton	California
United States	Health First Medical Group	Fort Worth	Texas
United States	Comprehensive Pain Specialists	Hendersonville	Tennessee
United States	Chandler Medical Center; Ken Muse Research	Lexington	Kentucky
United States	Mobile Infirmary Medical Center / Wilmax Clinical Research, Inc.	Mobile	Alabama
United States	Springhill Hospital / Wilmax Clinical Research, Inc.	Mobile	Alabama
United States	Baptist Medical Center South / Drug Research and Analysis Corporation	Montgomery	Alabama
United States	Jackson Hospital / Drug Research and Analysis Corporation	Montgomery	Alabama
United States	Arizona Research Center	Phoenix	Arizona
United States	Research Support Personnel LLC	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Cumberland Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Patient Demand for the Narcotic Analgesic, Morphine, Post Surgery	Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 24 hour period post-surgery	24 Hours	No