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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00225732
First Posted: September 26, 2005
Last Update Posted: June 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cumberland Pharmaceuticals
September 22, 2005
September 26, 2005
April 1, 2011
September 15, 2011
June 22, 2016
January 2005
January 2008   (Final data collection date for primary outcome measure)
Change in the Patient Demand for the Narcotic Analgesic, Morphine, Post Surgery [ Time Frame: 24 Hours ]
Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 24 hour period post-surgery
Morphine Use
Complete list of historical versions of study NCT00225732 on ClinicalTrials.gov Archive Site
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Not Provided
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Trial of Caldolor for Treatment of Pain in Post-Operative Adult Patients
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial of Ibuprofen Injection (IVIb) for Treatment of Pain in the Post-Operative Adult Patients
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pain
  • 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
  • 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
  • Active Comparator: intravenous ibuprofen
    Intervention: Drug: Intravenous ibuprofen
  • Placebo Comparator: normal saline
    Intervention: Other: Normal saline as placebo comparator
Southworth S, Peters J, Rock A, Pavliv L. A multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen 400 and 800 mg every 6 hours in the management of postoperative pain. Clin Ther. 2009 Sep;31(9):1922-35. doi: 10.1016/j.clinthera.2009.08.026.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
319
January 2008
January 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   United States
 
 
NCT00225732
CPI-CL-008
Yes
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Cumberland Pharmaceuticals
Cumberland Pharmaceuticals
Not Provided
Not Provided
Cumberland Pharmaceuticals
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP