Clinical trial NCT00470600: Efficacy and Safety Study of Caldolor (IV Ibuprofen) in Hospitalized Adult Orthopedic Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Lead sponsor: Cumberland Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-05-08
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: AUC-VAS With Movement (Post-operative Period, Hour-6-28)
timeFrame: Study hour-6 through hour-28
Secondary outcomes:
measure: Secondary Endpoint: AUC-VAS at Rest (Post-operative Period, Hours 6-28)
timeFrame: Study hour-6 through hour-28
measure: Patient Demand of Narcotic Use (Post-operative Period, From Hour 6 to 28).
timeFrame: Study hour-6 to hour-28
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Wilmax Clinical Research Inc.
state: Alabama
city: Little Rock
country: United States
facility: Teton Research, LLC
state: Arkansas
city: Arcadia
country: United States
facility: Clinical Management Services, Inc.
state: California
city: Atlanta
country: United States
facility: Southeastern Center for Clinical Trials
state: Georgia
city: Houston
country: United States
facility: Research Concepts, Inc
state: Texas
city: Houston
country: United States
facility: Research Concepts, Inc.
state: Texas
city: Johannesburg
country: South Africa
facility: Johannesburg General Hospital
city: Krugersdorp
country: South Africa
facility: Krugersdorp Private Hospital
city: Pretoria
country: South Africa
facility: Eugene Marais Hospital
Study officials:
affiliation: Lotus Clinical Research/Methodist Hospital of Southern CA
name: Neil Singla, MD
role: PRINCIPAL_INVESTIGATOR
References: