Clinical trial NCT00598559: Safety and Efficacy of Intravenous Acetaminophen (IV APAP) in Adult Inpatients
Official title: A Phase III, Multi-Center, Open-Label, Prospective, Repeated Dose, Randomized, Controlled, Multi-Day Study of the Safety and Efficacy of Intravenous Acetaminophen in Adult Inpatients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Pain
Fever
Keywords: Acute pain
Fever
IV Acetaminophen
Analgesic
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2008-01-22
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE).
timeFrame: T0 (first dose of IV APAP or randomization to SOC group) to Day 7 - 12 Follow-up
measure: Subjects Who Experienced at Least One Serious Treatment-Emergent Adverse Event (TEAE)
timeFrame: First dose (T0) to within 30 days of the last dose of study medication.
Secondary outcomes:
measure: Subject Global Evaluation of the Level of Satisfaction With Side Effects Related to Study Treatments
timeFrame: End of Day 5 (prior to discharge)
measure: Subject Global Evaluation of the Level of Satisfaction With Study Treatments Looking Back Over the Entire Treatment Period.
timeFrame: Study period lookback at Day 7
Other outcomes:
Locations:
city: Arcadia
country: United States
facility: Arcadia Methodist Hospital
state: California
city: Glendale
country: United States
facility: Glendale Adventist Medical Center
state: California
city: Laguna Hills
country: United States
facility: Accurate Clinical Trials, Inc.
state: California
city: Pasadena
country: United States
facility: Huntington Memorial Hospital
state: California
city: Pasadena
country: United States
facility: Lotus Clinical Research, Inc.
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
city: Crystal River
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Fort Pierce
country: United States
facility: G&G Research
state: Florida
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health Science University
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Houston
country: United States
facility: Memorial Herman/Memorial City Hospital
state: Texas
Study officials:
affiliation: Thomas Jefferson University
name: Eugene Viscusi, MD
role: PRINCIPAL_INVESTIGATOR
References: