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

This study has been completed.
Sponsor:
Information provided by:
Cadence Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00598702
First received: January 9, 2008
Last updated: January 10, 2011
Last verified: January 2011
  Purpose

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


Condition Intervention Phase
Pain
Fever
Drug: IV Acetaminophen
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Multi-Center, Open-Label, Prospective, Repeated Dose, Multi-Day Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients.

Resource links provided by NLM:


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: First dose to end of treatment period ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

    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


Secondary Outcome Measures:
  • Subject's (Parent/Guardian) Global Evaluation of Study Treatment [ Time Frame: Day 0 to Day 5, Day 7 or Early Termination from study ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Physicians were asked to evaluate the overall study treatment using a 4-point categorical evaluation scale (0= poor, 1= fair,2=good, 3= excellent).


Enrollment: 100
Study Start Date: January 2008
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IV Acetaminophen
40 to 75 mg/kg/day every 4 to 6 hours
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   37 Weeks to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598702

Locations
United States, California
Lucile Salter Packard Children's Hospital at Stanford
Stanford, California, United States, 94305
United States, Delaware
Alfred Dupont Hospital for Children
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Children's National Medical Center
Washington, DC, District of Columbia, United States, 20010
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Michigan
University of Michigan Ann Arbor
Ann Arbor, Michigan, United States, 48109
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65212
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
SUNY Stony Brook
Stony Brook, New York, United States, 11794
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Houston Neonatal-Perinatal Physicians
Bellaire, Texas, United States, 77401
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Cadence Pharmaceuticals
Investigators
Study Director: Mike Royal, MD, JD, MBA Cadence Pharmaceuticals
  More Information

No publications provided

Responsible Party: Mike Royal MD JD MBA, VP Clinical Development, Analgesics, Cadence Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00598702     History of Changes
Other Study ID Numbers: CPI-APA-352
Study First Received: January 9, 2008
Results First Received: September 25, 2009
Last Updated: January 10, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acetaminophen
Analgesics
Analgesics, Non-Narcotic
Antipyretics
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014