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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00470600
First received: May 7, 2007
Last updated: November 3, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Pain
Drug: Caldolor
Other: Normal Saline
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Cumberland Pharmaceuticals:

Primary Outcome Measures:
  • AUC-VAS With Movement (Post-operative Period, Hour-6-28) [ Time Frame: Study hour-6 through hour-28 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Secondary Endpoint: AUC-VAS at Rest (Post-operative Period, Hours 6-28) [ Time Frame: Study hour-6 through hour-28 ] [ Designated as safety issue: No ]
    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).

  • Patient Demand of Narcotic Use (Post-operative Period, From Hour 6 to 28). [ Time Frame: Study hour-6 to hour-28 ] [ Designated as safety issue: No ]
    Patient demand of narcotic used by patients in each treatment group for analgesia, post-surgery.


Enrollment: 185
Study Start Date: May 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Normal Saline
250 milliliters normal saline as a placebo comparator was administered every 6 hours for a total of five doses over the first 24 hours. Those patients who received the initial five doses could continue to receive additional doses as needed every 6 hours through the 120-hour treatment period.
Other: Normal Saline
Placebo comparator
Other Name: NS
Experimental: Intravenous ibuprofen
800 mg of intravenous ibuprofen diluted in 250 milliliters normal saline was administered every 6 hours for a total of five doses over the first 24 hours. Those patients who received the initial five doses could continue to receive additional doses as needed every 6 hours through the 120-hour treatment period.
Drug: Caldolor
800 milligrams intravenous
Other Name: Ibuprofen

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00470600

Locations
United States, Alabama
Wilmax Clinical Research Inc.
Mobile, Alabama, United States, 336608
United States, Arkansas
Teton Research, LLC
Little Rock, Arkansas, United States, 72205
United States, California
Clinical Management Services, Inc.
Arcadia, California, United States, 91007
United States, Georgia
Southeastern Center for Clinical Trials
Atlanta, Georgia, United States, 30350
United States, Texas
Research Concepts, Inc.
Houston, Texas, United States, 77401
Research Concepts, Inc
Houston, Texas, United States, 77054
South Africa
Johannesburg General Hospital
Johannesburg, South Africa
Krugersdorp Private Hospital
Krugersdorp, South Africa
Eugene Marais Hospital
Pretoria, South Africa
Sponsors and Collaborators
Cumberland Pharmaceuticals
Investigators
Principal Investigator: Neil Singla, MD Lotus Clinical Research/Methodist Hospital of Southern CA
  More Information

No publications provided

Responsible Party: Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00470600     History of Changes
Other Study ID Numbers: CPI-CL-008C
Study First Received: May 7, 2007
Results First Received: April 7, 2011
Last Updated: November 3, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 21, 2014