Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01334944
First received: April 12, 2011
Last updated: May 20, 2014
Last verified: May 2014
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pain: Patients with baseline VAS 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
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: 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

No publications provided

Responsible Party: Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01334944     History of Changes
Other Study ID Numbers: CPI-CL-015
Study First Received: April 12, 2011
Results First Received: April 15, 2014
Last Updated: May 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cumberland Pharmaceuticals:
Pain
Fever

Additional relevant MeSH terms:
Fever
Body Temperature Changes
Signs and Symptoms
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 20, 2014