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

This study has been completed.
Sponsor:
Information provided by:
Cadence Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00598559
First received: January 8, 2008
Last updated: November 11, 2010
Last verified: November 2010

January 8, 2008
November 11, 2010
January 2008
November 2008   (final data collection date for primary outcome measure)
  • 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
Spontaneous SAE Reports. [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00598559 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
Safety and Efficacy of Intravenous Acetaminophen (IV APAP) in Adult Inpatients
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

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.

• 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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Pain
  • Fever
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: 1 g IV Acetaminophen
    1 g q6h IV Acetaminophen
    Intervention: Drug: IV Acetaminophen
  • Experimental: 650 mg IV Acetaminophen
    650 mg q4h IV Acetaminophen
    Intervention: Drug: IV Acetaminophen
  • 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.
    Intervention: Drug: IV Acetaminophen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
213
November 2008
November 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00598559
CPI-APA-351
No
Cadence Pharmaceuticals
Cadence Pharmaceuticals
Not Provided
Principal Investigator: Eugene Viscusi, MD Thomas Jefferson University
Cadence Pharmaceuticals
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP