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

Completed · Phase 3

Conditions studied: Acute Pain, Fever

In brief

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.

Key facts

Study ID

NCT00598559

Run by

Mallinckrodt

People needed

213

Starts

2008-01-01

Expected to finish

2008-11-01

Last updated by the study team

2016-10-21

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 of IV treatment either because of having a "nothing by mouth" (NPO) status having a medical condition that makes oral intake difficult having a medical condition that requires IV treatment
• Be willing to undergo 5 days of treatment with IV acetaminophen for the treatment of pain or fever (defined as a core temperature greater than or equal to 38 degrees celsius). Note that Subjects have a slightly less than 15% chance (one in seven) of being assigned to the Control Group and receiving standard of care treatment, but no IV APAP.
• Have the ability to read and understand the Study procedures and have the ability to communicate meaningfully with the Study Investigator and staff
• If a female of child bearing potential, have a negative pregnancy test within 48 hours of randomization

You may not qualify if…

• Has a significant medical disease, laboratory abnormality or condition that, in the Investigator's judgment, could compromise the Subject's welfare or would otherwise contraindicate Study participation
• Is expected to have difficulty in communicating with the Study staff or completing Study 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 or equal to 3 times the upper limit of normal (ULN), bilirubin greater than or equal to 3 times ULN, known active hepatic disease (e.g., hepatitis), evidence of clinically significant 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 marketed product) within 30 days of Study entry

Where it is running

• Arcadia Methodist Hospital — Arcadia, California, United States
• Glendale Adventist Medical Center — Glendale, California, United States
• Accurate Clinical Trials, Inc. — Laguna Hills, California, United States
• Huntington Memorial Hospital — Pasadena, California, United States
• Lotus Clinical Research, Inc. — Pasadena, California, United States
• Santa Barbara Cottage Hospital — Santa Barbara, California, United States
• Nature Coast Clinical Research — Crystal River, Florida, United States
• G&G Research — Ft. Pierce, Florida, United States
• University of Miami School of Medicine — Miami, Florida, United States
• Weill Medical College of Cornell University — New York, New York, United States
• The Ohio State University Medical Center — Columbus, Ohio, United States
• Oregon Health Science University — Portland, Oregon, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Memorial Herman/Memorial City Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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