Phase
Condition
Pain
Acute Pain
Fever
Treatment
N/AClinical Study ID
Ages 18-85 All Genders
Study Summary
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
Study Description
Connect with a study center
Arcadia Methodist Hospital
Arcadia, California 91007
United StatesSite Not Available
Glendale Adventist Medical Center
Glendale, California 91206
United StatesSite Not Available
Accurate Clinical Trials, Inc.
Laguna Hills, California 92653
United StatesSite Not Available
Huntington Memorial Hospital
Pasadena, California 91105
United StatesSite Not Available
Lotus Clinical Research, Inc.
Pasadena, California 91105
United StatesSite Not Available
Santa Barbara Cottage Hospital
Santa Barbara, California 93105
United StatesSite Not Available
Nature Coast Clinical Research
Crystal River, Florida 34429
United StatesSite Not Available
G&G Research
Fort Pierce, Florida 34950
United StatesSite Not Available
University of Miami School of Medicine
Miami, Florida 33136
United StatesSite Not Available
Weill Medical College of Cornell University
New York, New York 10021
United StatesSite Not Available
The Ohio State University Medical Center
Columbus, Ohio 43210
United StatesSite Not Available
Oregon Health Science University
Portland, Oregon 97239
United StatesSite Not Available
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Memorial Herman/Memorial City Hospital
Houston, Texas 77024
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.