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Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients
This study is currently recruiting participants.
Verified by Cadence Pharmaceuticals, October 2008
Sponsored by: Cadence Pharmaceuticals
Information provided by: Cadence Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00598702
  Purpose

IV APAP 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 APAP Acetaminophen
Phase III

MedlinePlus related topics: Fever
Drug Information available for: Acetaminophen
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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.

Further study details as provided by Cadence Pharmaceuticals:

Primary Outcome Measures:
  • To assess safety of IV APAP (% of subjects with AEs, % of subjects withdrawn due to SAEs, % of subjects with SAEs, clinically meaningful changes from baseline labs) in pediatric inpatients treated for acute pain or fever in various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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: January 2008
Estimated Study Completion Date: April 2008
Estimated Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
IV APAP
Drug: IV APAP Acetaminophen
o Target is 5 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

Detailed Description:

To assess the safety of IV APAP when used over five or more days for the treatment of acute pain or fever in pediatric (neonates, infants, children and adolescents) inpatients who are NPO, require or would benefit from IV treatment, or are willing and able to stay on IV APAP therapy for 5 to 7 days

  Eligibility

Ages Eligible for Study:   37 Weeks to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 five days) use of 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., 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) 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00598702

Contacts
Contact: Mike Royal, MD, JD, MBA 858-436-1427 mroyal@cadencepharm.com
Contact: Lola Fong 858-436-1438 lfong@cadencepharm.com

Locations
United States, California
Lucile Salter Packard Children's Hospital at Stanford Recruiting
Stanford, California, United States, 94305
United States, Delaware
Alfred Dupont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, DC, District of Columbia, United States, 20010
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
United States, Michigan
University of Michigan Ann Arbor Recruiting
Ann Arbor, Michigan, United States, 48109
United States, Missouri
University of Missouri Recruiting
Columbia, Missouri, United States, 65212
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
SUNY Stony Brook Recruiting
Stony Brook, New York, United States, 11794
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Thomas Jefferson University Not yet recruiting
Philadelphia, Pennsylvania, United States, 19107
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Houston Neonatal-Perinatal Physicians Recruiting
Bellaire, Texas, United States, 77401
Sponsors and Collaborators
Cadence Pharmaceuticals
Investigators
Study Director: Mike Royal, MD, JD, MBA Cadence Pharmaceuticals
  More Information

Responsible Party: Cadence Pharmaceuticals ( Mike Royal MD JD MBA, VP Clinical Development, Analgesics )
Study ID Numbers: CPI-APA-352
Study First Received: January 9, 2008
Last Updated: October 14, 2008
ClinicalTrials.gov Identifier: NCT00598702  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Fever
Pain
Acetaminophen

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

ClinicalTrials.gov processed this record on January 14, 2009