Efficacy and Safety Study of Caldolor (IV Ibuprofen) in Hospitalized Adult Orthopedic Patients

Pain Clinical Trial

Official title:

A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF IBUPROFEN INJECTION (IVIb) FOR TREATMENT OF PAIN IN POST-OPERATIVE ORTHOPEDIC ADULT PATIENTS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00470600
• Other study ID #: CPI-CL-008C
• Status: Completed
• Phase: Phase 3
• First received: May 7, 2007
• Last updated: August 3, 2015
• Start date: May 2007
• Est. completion date: September 2008

Study information

• Verified date: August 2015
• 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 orthopedic patients every 6 hours for at least 24 hours is to determine the efficacy of Caldolor (IV ibuprofen) compared to placebo for the treatment of post-operative pain by patients self-assessment of pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Scheduled for elective hip or knee replacement, reconstruction or arthroplasty surgery with anticipated need for post-operative intravenous (IV) morphine analgesia with anticipated use of (greater than or equal to (=) 28 hours.

2. Adequate IV access

3. Anticipated hospital stay = 28 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 80 years of age

4. Use of analgesics, muscle relaxants, NSAIDS and sedatives less than 12 hours prior to clinicaltrial material(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

5. Patients taking warfarin, lithium, combination of angiotension converting enzyme(ACE)-inhibitors and furosemide

6. Patients with anemia (active, clinically significant anemia) and/or a history or evidence of asthma or heart failure

7. History of allergy or hypersensitivity to any component of Caldolor, aspirin (or aspirin related products), NSAIDs, or COX-2 inhibitors

8. Pregnant or nursing

9. 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

10. Weigh less than 30 kilogram

11. Have a history of congenital bleeding diathesis (e.g. 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

12. Have gastrointestional (GI) bleeding that required medical intervention within the previous 6 weeks (unless definitive surgery has been performed)

13. Have a platelet count less than 30,000 mm^3 determined within the 28 days prior to surgery

14. Pre-existing dependence on narcotics or known tolerance to opioids

15. 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

16. Refusal to provide written authorization for use and disclosure of protected health information

17. Be on dialysis, have oliguria or creatinine greater than 3.0 milligram/deciliter.

18. Inability to achieve hemostasis or inability to close surgical incision, prior to Operating Room discharge

19. Operative procedure includes organ transplant

20. Pre or intra-operative procedure utilized for the prevention of pre- or post-operative pain (i.e. epidural or nerve blocks)

21. Be receiving full dose anticoagulation therapy or Activated Protein C within 6 hours before dosing (Prophylaxis with subcutaneous heparin is acceptable)

22. Have received another investigational drug within the past 30 days

23. Be otherwise unsuitable for the study in the opinion of the investigator

Study Design

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Caldolor
800 milligrams intravenous

Other:
• Normal Saline
Placebo comparator

Locations

Country	Name	City	State
South Africa	Johannesburg General Hospital	Johannesburg
South Africa	Krugersdorp Private Hospital	Krugersdorp
South Africa	Eugene Marais Hospital	Pretoria
United States	Clinical Management Services, Inc.	Arcadia	California
United States	Southeastern Center for Clinical Trials	Atlanta	Georgia
United States	Research Concepts, Inc	Houston	Texas
United States	Research Concepts, Inc.	Houston	Texas
United States	Teton Research, LLC	Little Rock	Arkansas
United States	Wilmax Clinical Research Inc.	Mobile	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Cumberland Pharmaceuticals

Countries where clinical trial is conducted

United States,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC-VAS With Movement (Post-operative Period, Hour-6-28)	Measurement of the patient's self assessment of pain with movement using the validated visual analog scale (VAS) during the post-operative period (study hour-6 through hour-28). VAS assessments document the patient's self reported level of pain from "No pain" (0 mm) to "Worst possible pain" (100 mm) on a 100 mm line. VAS assessments were performed immediately following surgery [variable since every surgery has a unique length of time even if it is the same procedure] and at hours 6, 8, 12, 16, 20, 24 and 28 (for the primary endpoint).	Study hour-6 through hour-28	No
Secondary	Secondary Endpoint: AUC-VAS at Rest (Post-operative Period, Hours 6-28)	Measurement of the patient's self assessment of pain at rest using a visual analog scale (VAS) during the post-operative period (study hour-6 through hour-28). VAS assessments document the patient's self reported level of pain from "No pain" (0 mm) to "Worst possible pain" (100 mm) on a 100 mm line. VAS assessments were performed immediately following surgery and at hours 6, 8, 12, 16, 20, 24 and 28 (for the primary endpoint).	Study hour-6 through hour-28	No
Secondary	Patient Demand of Narcotic Use (Post-operative Period, From Hour 6 to 28).	Patient demand of narcotic used by patients in each treatment group for analgesia, post-surgery.	Study hour-6 to hour-28	No