Safety and Efficacy of Intravenous Acetaminophen (IV APAP) in Adult Inpatients

Last updated: September 8, 2016
Sponsor: Mallinckrodt
Overall Status: Completed

Phase

3

Condition

Pain

Acute Pain

Fever

Treatment

N/A

Clinical Study ID

NCT00598559
CPI-APA-351
  • Ages 18-85
  • All Genders

Study Summary

The study will be investigating safety and efficacy administration of repeated dose of IV Acetaminophen (IV APAP) over five days for the treatment of acute pain or fever in adult patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Provide written informed consent prior to participation in the Study

  • Be at least 18 years of age and weigh at least 41 kilogram (kg)

  • Be anticipated by the Investigator to require multi-day (target is five days) use ofIV treatment either because of having a "nothing by mouth" (NPO) status having amedical condition that makes oral intake difficult having a medical condition thatrequires IV treatment

  • Be willing to undergo 5 days of treatment with IV acetaminophen for the treatment ofpain or fever (defined as a core temperature greater than or equal to 38 degreescelsius). Note that Subjects have a slightly less than 15% chance (one in seven) ofbeing assigned to the Control Group and receiving standard of care treatment, but noIV APAP.

  • Have the ability to read and understand the Study procedures and have the ability tocommunicate meaningfully with the Study Investigator and staff

  • If a female of child bearing potential, have a negative pregnancy test within 48 hoursof randomization

Exclusion

Exclusion Criteria:

  • Has a significant medical disease, laboratory abnormality or condition that, in theInvestigator's judgment, could compromise the Subject's welfare or would otherwisecontraindicate Study participation

  • Is expected to have difficulty in communicating with the Study staff or completingStudy requirements (including follow up visits)

  • Has known hypersensitivity to acetaminophen or the inactive ingredients (excipients)of IV acetaminophen or any contraindication to receiving acetaminophen

  • Has impaired liver function, e.g., Alanine aminotransferase (ALT) greater than orequal to 3 times the upper limit of normal (ULN), bilirubin greater than or equal to 3times ULN, known active hepatic disease (e.g., hepatitis), evidence of clinicallysignificant chronic liver disease or other condition affecting the liver (e.g.,alcoholism as defined by DSM-IV, cirrhosis or chronic hepatitis)

  • Has participated in an interventional clinical Study (investigational or marketedproduct) within 30 days of Study entry

Study Design

Total Participants: 213
Study Start date:
January 01, 2008
Estimated Completion Date:
November 30, 2008

Study Description

• To assess the safety of IV Acetaminophen when used over five days for the treatment of acute pain or fever in adult inpatients

Secondary Objectives:

  • To compare the efficacy of IV Acetaminophen 650 milligram (mg) every four (q4) hours vs. 1 gram (g) every 6 (q6) hours over 5 days of treatment

  • To compare the safety of IV Acetaminophen 650 mg q4 hours vs. 1 g q6 hours over 5 days of treatment

  • To compare the safety of IV Acetaminophen vs. standard of care (SOC) treatment over 5 days of treatment

  • To compare the efficacy of IV Acetaminophen vs. standard of care treatment over 5 days of treatment

Connect with a study center

  • Arcadia Methodist Hospital

    Arcadia, California 91007
    United States

    Site Not Available

  • Glendale Adventist Medical Center

    Glendale, California 91206
    United States

    Site Not Available

  • Accurate Clinical Trials, Inc.

    Laguna Hills, California 92653
    United States

    Site Not Available

  • Huntington Memorial Hospital

    Pasadena, California 91105
    United States

    Site Not Available

  • Lotus Clinical Research, Inc.

    Pasadena, California 91105
    United States

    Site Not Available

  • Santa Barbara Cottage Hospital

    Santa Barbara, California 93105
    United States

    Site Not Available

  • Nature Coast Clinical Research

    Crystal River, Florida 34429
    United States

    Site Not Available

  • G&G Research

    Fort Pierce, Florida 34950
    United States

    Site Not Available

  • University of Miami School of Medicine

    Miami, Florida 33136
    United States

    Site Not Available

  • Weill Medical College of Cornell University

    New York, New York 10021
    United States

    Site Not Available

  • The Ohio State University Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Oregon Health Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Memorial Herman/Memorial City Hospital

    Houston, Texas 77024
    United States

    Site Not Available

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