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Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01334944
First Posted: April 13, 2011
Last Update Posted: September 2, 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
  Purpose
The primary objective of this study is to determine the safety of a single dose of intravenous ibuprofen administered over 5-10 minutes for the treatment of fever or pain in the hospital setting.

Condition Intervention Phase
Pain Fever Drug: Intravenous ibuprofen Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, Open-Label, Surveillance Trial To Evaluate The Safety and Efficacy of a Shortened Infusion Time of Intravenous Ibuprofen.

Resource links provided by NLM:


Further study details as provided by Cumberland Pharmaceuticals:

Primary Outcome Measures:
  • To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting. [ Time Frame: 6 hours ]
    The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen

  • To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting. [ Time Frame: 6 hours ]
    The incidence of treatment-emergent adverse events occurring in the six hours following administration of intravenous ibuprofen.

  • To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting [ Time Frame: 1 hour ]
    The change from baseline to one hour post administration of intravenous ibuprofen in vitals sign assessments (Temperature)

  • To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting. [ Time Frame: 1 hour ]
    The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Heart Rate).

  • To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting. [ Time Frame: 1 hour ]
    The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Respiratory Rate).

  • To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting. [ Time Frame: 1 hour ]
    The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Systolic Blood Pressure).

  • To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting. [ Time Frame: 1 hour ]
    The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Diastolic Blood Pressure).


Secondary Outcome Measures:
  • To Determine the Efficacy of a Single Dose of 400 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever [ Time Frame: 4 hours ]
    The change in temperature from baseline over the 4 hours following intravenous ibuprofen administration

  • To Determine the Efficacy of a Single Dose of 800 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Pain (Mild to Moderate or Moderate to Severe). [ Time Frame: 4 hours ]
    The change in patient self-assessment of pain utilizing the visual analog scale (VAS) from baseline over the 4 hours following intravenous ibuprofen administration. The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between o and 100.

  • To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain [ Time Frame: 24 hours ]
    The incidence of treatment-emergent serious adverse events occurring through extended dosing.

  • To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain [ Time Frame: 24 hours ]
    The incidence of treatment-emergent adverse events occurring through extended dosing.


Enrollment: 150
Study Start Date: June 2011
Study Completion Date: October 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intravenous ibuprofen
Intravenous ibuprofen (400 mg or 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
Drug: Intravenous ibuprofen
400 mg or 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes
Other Name: Caldolor

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pain: Patients with baseline Visual Analog Scale assessment >3, -and/or- Fever: Patients with temperature >101°F.

Exclusion Criteria:

  1. Patients with inadequate IV access
  2. Patients <18 years of age
  3. History or allergy or hypersensitivity to any component of intravenous ibuprofen, aspirin (or aspirin related products) or non-steroidal anti-inflammatory drug (NSAIDs)
  4. Active hemorrhage or clinically significant bleeding
  5. Pregnant or nursing
  6. Patients in the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery
  7. 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
  8. Refusal to provide written authorization for use and disclosure of protected health information
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01334944


Locations
United States, California
UCSD
San Diego, California, United States, 92103
United States, Connecticut
Danbury
Danbury, Connecticut, United States, 06810
United States, Florida
University of Miami - Miller School of Medicine
Miami, Florida, United States, 33136
United States, Georgia
Grady
Atlanta, Georgia, United States, 30303
United States, Massachusetts
Beth Israel Deaconnes MC
Boston, Massachusetts, United States, 02215
United States, New York
Columbia
New York, New York, United States, 10032
United States, North Carolina
The University of North Carolina Hospitals
Chapel Hill, North Carolina, United States, 27599
Duke University Medical Center
Durham, North Carolina, United States, 27710
The Moses H. Cone Memorial Hospital
Greensboro, North Carolina, United States, 27401-1020
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Fairview
Cleveland, Ohio, United States, 44111
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Lankenau
Wynnewood, Pennsylvania, United States, 19096
Sponsors and Collaborators
Cumberland Pharmaceuticals
Investigators
Study Director: Art P Wheeler, M.D. Cumberland Pharmaceuticals Inc.
  More Information

Responsible Party: Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01334944     History of Changes
Other Study ID Numbers: CPI-CL-015
First Submitted: April 12, 2011
First Posted: April 13, 2011
Results First Submitted: April 15, 2014
Results First Posted: June 23, 2014
Last Update Posted: September 2, 2016
Last Verified: July 2016

Keywords provided by Cumberland Pharmaceuticals:
Pain
Fever

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
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action