Safety and Efficacy of Intravenous Acetaminophen (IV APAP) in Adult Inpatients - Full Text View

Purpose

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.

Condition	Intervention	Phase
Acute Pain Fever	Drug: IV Acetaminophen	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Fever

Drug Information available for: Acetaminophen

U.S. FDA Resources

Further study details as provided by Cadence Pharmaceuticals:

Primary Outcome Measures:

Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE). [ Time Frame: T0 (first dose of IV APAP or randomization to SOC group) to Day 7 - 12 Follow-up ] [ Designated as safety issue: Yes ]
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) [ Time Frame: First dose (T0) to within 30 days of the last dose of study medication. ] [ Designated as safety issue: Yes ]
Serious TEAE is any untoward medical occurrences at any dose of study medication that:
- results in death
- is life threatening
- requires inpatient hopsitalization 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:

Subject Global Evaluation of the Level of Satisfaction With Side Effects Related to Study Treatments [ Time Frame: End of Day 5 (prior to discharge) ] [ Designated as safety issue: No ]
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. [ Time Frame: Study period lookback at Day 7 ] [ Designated as safety issue: No ]
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.

Enrollment:	213
Study Start Date:	January 2008
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 g IV Acetaminophen 1 g q6h IV Acetaminophen	Drug: IV Acetaminophen Arm 1: 1 g IV Acetaminophen every 6 hours administered for five days. Arm 2: 650 mg IV Acetaminophen every 4 hours administered for five days. Arm 3: 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. Other Name: IV Acetaminophen (IV APAP)
Experimental: 650 mg IV Acetaminophen 650 mg q4h IV Acetaminophen	Drug: IV Acetaminophen Arm 1: 1 g IV Acetaminophen every 6 hours administered for five days. Arm 2: 650 mg IV Acetaminophen every 4 hours administered for five days. Arm 3: 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. Other Name: IV Acetaminophen (IV APAP)
Standard of Care 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.	Drug: IV Acetaminophen Arm 1: 1 g IV Acetaminophen every 6 hours administered for five days. Arm 2: 650 mg IV Acetaminophen every 4 hours administered for five days. Arm 3: 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. Other Name: IV Acetaminophen (IV APAP)

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

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598559

Locations

United States, California
Arcadia Methodist Hospital
Arcadia, California, United States, 91007
Glendale Adventist Medical Center
Glendale, California, United States, 91206
Accurate Clinical Trials, Inc.
Laguna Hills, California, United States, 92653
Lotus Clinical Research, Inc.
Pasadena, California, United States, 91105
Huntington Memorial Hospital
Pasadena, California, United States, 91105
Santa Barbara Cottage Hospital
Santa Barbara, California, United States, 93105
United States, Florida
Nature Coast Clinical Research
Crystal River, Florida, United States, 34429
G&G Research
Fort Pierce, Florida, United States, 34950
University of Miami School of Medicine
Miami, Florida, United States, 33136
United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10021
United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Memorial Herman/Memorial City Hospital
Houston, Texas, United States, 77024

Sponsors and Collaborators

Cadence Pharmaceuticals

Investigators

Principal Investigator:

Eugene Viscusi, MD

Thomas Jefferson University

More Information

No publications provided

Responsible Party:	Cadence Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00598559 History of Changes
Other Study ID Numbers:	CPI-APA-351
Study First Received:	January 8, 2008
Results First Received:	September 25, 2009
Last Updated:	November 11, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cadence Pharmaceuticals:

Acute pain
Fever
IV Acetaminophen
Analgesic

Additional relevant MeSH terms:

Fever
Body Temperature Changes
Signs and Symptoms
Acetaminophen
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions

Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013