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Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen

Information source: Cumberland Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain; Fever

Intervention: Intravenous ibuprofen (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Cumberland Pharmaceuticals

Official(s) and/or principal investigator(s):
Art P Wheeler, M.D., Study Director, Affiliation: Cumberland Pharmaceuticals Inc.

Summary

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.

Clinical Details

Official title: A Multi-Center, Open-Label, Surveillance Trial To Evaluate The Safety and Efficacy of a Shortened Infusion Time of Intravenous Ibuprofen.

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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.

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.

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

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.

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.

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.

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.

Secondary outcome:

To Determine the Efficacy of a Single Dose of 400 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever

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).

To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain

To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

UCSD, San Diego, California 92103, United States

Danbury, Danbury, Connecticut 06810, United States

University of Miami - Miller School of Medicine, Miami, Florida 33136, United States

Grady, Atlanta, Georgia 30303, United States

Beth Israel Deaconnes MC, Boston, Massachusetts 02215, United States

Columbia, New York, New York 10032, United States

The University of North Carolina Hospitals, Chapel Hill, North Carolina 27599, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

The Moses H. Cone Memorial Hospital, Greensboro, North Carolina 27401-1020, United States

Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina 27157, United States

Fairview, Cleveland, Ohio 44111, United States

The Ohio State University Medical Center, Columbus, Ohio 43210, United States

Lankenau, Wynnewood, Pennsylvania 19096, United States

Additional Information

Starting date: June 2011
Last updated: May 20, 2014

Page last updated: August 23, 2015

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