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

Phase 3

Completed

Brief 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.

Detailed 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

Recruitment & Eligibility

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 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

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
1 g IV Acetaminophen	IV Acetaminophen	1 g q6h IV Acetaminophen
650 mg IV Acetaminophen	IV Acetaminophen	650 mg q4h IV Acetaminophen
Standard of Care	IV Acetaminophen	The standard of care treatments were defined as any medication the investigator deemed appropriate to treat the subject, including products containing acetaminophen but excluding IV acetaminophen.

Primary Outcome Measures

Name	Time	Method
Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE).	T0 (first dose of IV APAP or randomization to SOC group) to Day 7 - 12 Follow-up	Number of subjects who experienced at least one treatment emergent adverse event (TEAE). A TEAE is an adverse event that occurs on or after the first dose of study medication (T0).
Subjects Who Experienced at Least One Serious Treatment-Emergent Adverse Event (TEAE)	First dose (T0) to within 30 days of the last dose of study medication.	Serious TEAE is any untoward medical occurrences at any dose of study medication that: * results in death * is life threatening * requires inpatient hospitalization or causes prolongation of existing hospitalization * results in persistent or significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event

Secondary Outcome Measures

Name	Time	Method
Subject Global Evaluation of the Level of Satisfaction With Side Effects Related to Study Treatments	End of Day 5 (prior to discharge)	Using a four point categorical scale 0= poor, 1= fair, 2= good, 3= excellent, comparisons of subject's Global Evaluations of the level of satisfaction with side effects related to study treatment at End of Day 5 (prior to discharge)
Subject Global Evaluation of the Level of Satisfaction With Study Treatments Looking Back Over the Entire Treatment Period.	Study period lookback at Day 7	Using a four point categorical scale 0= poor, 1= fair, 2= good, 3= excellent, comparisons of subject's Global Evaluations of the level of satisfaction with study treatments looking back over the entire treatment period was conducted at Day 7.

Locations (14): Huntington Memorial Hospital
🇺🇸
Pasadena, California, United States
Santa Barbara Cottage Hospital
🇺🇸
Santa Barbara, California, United States
Nature Coast Clinical Research
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Crystal River, Florida, United States
Memorial Herman/Memorial City Hospital
🇺🇸
Houston, Texas, United States
The Ohio State University Medical Center
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Columbus, Ohio, United States
Oregon Health Science University
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Portland, Oregon, United States
Arcadia Methodist Hospital
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Arcadia, California, United States
Lotus Clinical Research, Inc.
🇺🇸
Pasadena, California, United States
G&G Research
🇺🇸
Fort Pierce, Florida, United States
University of Miami School of Medicine
🇺🇸
Miami, Florida, United States
Accurate Clinical Trials, Inc.
🇺🇸
Laguna Hills, California, United States
Weill Medical College of Cornell University
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New York, New York, United States
Glendale Adventist Medical Center
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Glendale, California, United States
Thomas Jefferson University
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Philadelphia, Pennsylvania, United States