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

This study has been completed.
Sponsor:
Information provided by:
Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00225732
First received: September 22, 2005
Last updated: August 10, 2011
Last verified: August 2011
  Purpose

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


Condition Intervention Phase
Pain
Other: Normal saline as placebo comparator
Drug: Intravenous ibuprofen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/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 the Post-Operative Adult Patients

Resource links provided by NLM:


Further study details as provided by Cumberland Pharmaceuticals:

Primary Outcome Measures:
  • Change in the Patient Demand for the Narcotic Analgesic, Morphine, Post Surgery [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]
    Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 24 hour period post-surgery


Enrollment: 319
Study Start Date: January 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: intravenous ibuprofen 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)

Other Name: Caldolor
Placebo Comparator: normal saline 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)
Other Name: NS

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225732

Locations
United States, Alabama
Medical Center East / Alabama Clinical Therapeutics
Birmingham, Alabama, United States, 35235
Cooper Green Hospital / Jefferson Clinic
Birmingham, Alabama, United States, 35233
Mobile Infirmary Medical Center / Wilmax Clinical Research, Inc.
Mobile, Alabama, United States, 36652-2144
Springhill Hospital / Wilmax Clinical Research, Inc.
Mobile, Alabama, United States, 36608
Jackson Hospital / Drug Research and Analysis Corporation
Montgomery, Alabama, United States, 36106
Baptist Medical Center South / Drug Research and Analysis Corporation
Montgomery, Alabama, United States, 36111
United States, Arizona
Arizona Research Center
Phoenix, Arizona, United States, 85023
United States, California
Valley OB/GYN
Colton, California, United States, 92324
United States, Kansas
Research Support Personnel LLC
Wichita, Kansas, United States, 67208
United States, Kentucky
Chandler Medical Center; Ken Muse Research
Lexington, Kentucky, United States, 40536
United States, Tennessee
Comprehensive Pain Specialists
Hendersonville, Tennessee, United States, 37075
United States, Texas
Health First Medical Group
Fort Worth, Texas, United States, 76135
Australia
Royal Adelaide Hospital
Adelaide, Australia, 5000
Sponsors and Collaborators
Cumberland Pharmaceuticals
  More Information

No publications provided by Cumberland Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amy Rock, Ph.D., Senior Manager, Regulatory Affiars, Cumberland Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00225732     History of Changes
Other Study ID Numbers: CPI-CL-008
Study First Received: September 22, 2005
Results First Received: April 1, 2011
Last Updated: August 10, 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 July 29, 2014