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

Primary Purpose

Acute Pain, Fever

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
IV Acetaminophen
Sponsored by
Mallinckrodt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring Acute pain, Fever, IV Acetaminophen, Analgesic

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arcadia Methodist Hospital
  • Glendale Adventist Medical Center
  • Accurate Clinical Trials, Inc.
  • Huntington Memorial Hospital
  • Lotus Clinical Research, Inc.
  • Santa Barbara Cottage Hospital
  • Nature Coast Clinical Research
  • G&G Research
  • University of Miami School of Medicine
  • Weill Medical College of Cornell University
  • The Ohio State University Medical Center
  • Oregon Health Science University
  • Thomas Jefferson University
  • Memorial Herman/Memorial City Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

1 g IV Acetaminophen

650 mg IV Acetaminophen

Standard of Care

Arm Description

1 g q6h IV Acetaminophen

650 mg q4h 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.

Outcomes

Primary Outcome Measures

Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE).
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)
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

Subject Global Evaluation of the Level of Satisfaction With Side Effects Related to Study Treatments
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.
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.

Full Information

First Posted
January 8, 2008
Last Updated
September 8, 2016
Sponsor
Mallinckrodt
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1. Study Identification

Unique Protocol Identification Number
NCT00598559
Brief Title
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

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mallinckrodt

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain, Fever
Keywords
Acute pain, Fever, IV Acetaminophen, Analgesic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
213 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 g IV Acetaminophen
Arm Type
Experimental
Arm Description
1 g q6h IV Acetaminophen
Arm Title
650 mg IV Acetaminophen
Arm Type
Experimental
Arm Description
650 mg q4h IV Acetaminophen
Arm Title
Standard of Care
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
IV Acetaminophen
Other Intervention Name(s)
IV Acetaminophen (IV APAP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE).
Description
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).
Time Frame
T0 (first dose of IV APAP or randomization to SOC group) to Day 7 - 12 Follow-up
Title
Subjects Who Experienced at Least One Serious Treatment-Emergent Adverse Event (TEAE)
Description
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
Time Frame
First dose (T0) to within 30 days of the last dose of study medication.
Secondary Outcome Measure Information:
Title
Subject Global Evaluation of the Level of Satisfaction With Side Effects Related to Study Treatments
Description
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)
Time Frame
End of Day 5 (prior to discharge)
Title
Subject Global Evaluation of the Level of Satisfaction With Study Treatments Looking Back Over the Entire Treatment Period.
Description
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.
Time Frame
Study period lookback at Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Viscusi, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arcadia Methodist Hospital
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
Facility Name
Glendale Adventist Medical Center
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Accurate Clinical Trials, Inc.
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Huntington Memorial Hospital
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Lotus Clinical Research, Inc.
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Santa Barbara Cottage Hospital
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Nature Coast Clinical Research
City
Crystal River
State/Province
Florida
ZIP/Postal Code
34429
Country
United States
Facility Name
G&G Research
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34950
Country
United States
Facility Name
University of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oregon Health Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Memorial Herman/Memorial City Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States

12. IPD Sharing Statement

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

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