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Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00598702
First Posted: January 22, 2008
Last Update Posted: May 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mallinckrodt
January 9, 2008
January 22, 2008
September 25, 2009
January 6, 2011
May 10, 2017
January 2008
December 2008   (Final data collection date for primary outcome measure)
  • Number of Subjects Reporting at Least One Treatment Emergent Adverse Event (TEAE) [ Time Frame: First dose to end of treatment period ]
    A TEAE is defined as an adverse event that starts on or after the start of study medication.
  • Number of Subjects Reporting at Least One Serious Treatment Emergent Adverse Event [ Time Frame: First dose to 30 days after last dose ]

    A Serious Treatment Emergent Adverse Event is defined as any untoward medical occurrence at any dose of IV APAP 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
To assess safety of IV APAP (% of subjects with AEs, % of subjects withdrawn due to SAEs, % of subjects with SAEs, clinically meaningful changes from baseline labs) in pediatric inpatients treated for acute pain or fever in various clinical settings [ Time Frame: Up to 7 days ]
Complete list of historical versions of study NCT00598702 on ClinicalTrials.gov Archive Site
  • Subject's (Parent/Guardian) Global Evaluation of Study Treatment [ Time Frame: Day 0 to Day 5, Day 7 or Early Termination from study ]
    Subject's (parent/guardian) was asked to evaluate the overall study treatment using a 4-point categorical evaluation scale (0= poor, 1= fair, 2=good, 3= excellent).
  • Physician's Global Assessment of Study Treatment [ Time Frame: End of study or Early Termination ]
    Physicians were asked to evaluate the overall study treatment using a 4-point categorical evaluation scale (0= poor, 1= fair,2=good, 3= excellent).
To assess the efficacy of IV APAP in an open-label, prospective fashion when used in a variety of clinical settings. [ Time Frame: Up to 7 days ]
Not Provided
Not Provided
 
Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients
A Phase III Multi-Center, Open-Label, Prospective, Repeated Dose, Multi-Day Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients.
Intravenous acetaminophen (IVAPAP) is safe in repeated dose, multi-day clinical use when administered at a daily dose of 40 to 75 mg/kg body weight
To assess the safety of intravenous acetaminophen (IV APAP) when used over one or more days for the treatment of acute pain or fever in pediatric (neonates, infants, children and adolescents) inpatients who are unable to take anything by mouth (NPO), require or would benefit from IV treatment, or are willing and able to stay on IVAPAP therapy for 1 to 7 days.
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Pain
  • Fever
Drug: IV Acetaminophen
Target is 1 to 7 days of therapy with intravenous (IV) Acetaminophen (IV APAP) at a dose of 40 to 75 mg/kg body weight/day administered as an IV infusion (or by syringe pump) over 15 minutes and given every 4 to 6 hours as a scheduled dose
Other Names:
  • IV APAP
  • APAP
Experimental: IV Acetaminophen
40 to 75 mg/kg/day every 4 to 6 hours
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
100
January 2009
December 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • The Subject's Parent or Guardian must provide written informed consent, with Subject assent where appropriate, prior to the Subject's participation in the Study.
  • Be less than 17 years of age and older than 37 weeks post conception
  • Anticipated by the Investigator to require multi-day (minimum of one day) use of intravenous (IV) treatment either because of a having a status of nothing by mouth (NPO) or a medical condition that makes oral intake difficult or be willing to undergo at least 5 days of treatment with IV acetaminophen for the treatment of pain or fever
  • Have the ability to read and understand the Study procedures and have the ability to communicate meaningfully with the Study Investigator and staff (if the Subject is of preverbal age or cannot read or communicate meaningfully, then the Subject's Parent or Guardian must meet this criterion)
  • If a female of child bearing potential, have a negative pregnancy test

Exclusion Criteria:

  • Has significant medical disease(s), laboratory abnormalities or condition(s) that in the Investigator's judgment could compromise the Subject's welfare, ability to communicate with the Study staff, complete Study activities, or would otherwise contraindicate Study participation
  • Has known hypersensitivity or contraindication to receiving IV acetaminophen or the inactive ingredients (excipients) of IV 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 the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), cirrhosis, or chronic hepatitis) that may suggest the potential for an increased susceptibility to hepatic toxicity with IV acetaminophen exposure
  • Has participated in an interventional clinical Study (investigational or marketed product) within 30 days of Study entry
Sexes Eligible for Study: All
37 Weeks to 16 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00598702
CPI-APA-352
No
Not Provided
Not Provided
Mallinckrodt
Mallinckrodt
Not Provided
Not Provided
Mallinckrodt
April 2017

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