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

NCT00598702 | Completed Phase 3 Results

• 1 other identifier: CPI-APA-352
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 14

Brief Summary

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

Conditions

Pain; Fever

Outcome Measures

Primary Outcomes (2)

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

  A TEAE is defined as an adverse event that starts on or after the start of study medication.

  First dose to end of treatment period

• Number of Subjects Reporting at Least One Serious Treatment Emergent Adverse Event

  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

  First dose to 30 days after last dose

Secondary Outcomes (2)

• Subject's (Parent/Guardian) Global Evaluation of Study Treatment

  Day 0 to Day 5, Day 7 or Early Termination from study

• Physician's Global Assessment of Study Treatment

  End of study or Early Termination

Study Arms (1)

IV Acetaminophen

EXPERIMENTAL

40 to 75 mg/kg/day every 4 to 6 hours

Drug: IV Acetaminophen

Interventions

IV Acetaminophen DRUG

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

Also known as: IV APAP, APAP

IV Acetaminophen

Eligibility Criteria

• Age: 37 Weeks - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mallinckrodt: lead

Study Sites (14)

Lucile Salter Packard Children's Hospital at Stanford

Stanford, California, 94305, United States

Location

Alfred Dupont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

University of Michigan Ann Arbor

Ann Arbor, Michigan, 48109, United States

Location

University of Missouri

Columbia, Missouri, 65212, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

SUNY Stony Brook

Stony Brook, New York, 11794, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Houston Neonatal-Perinatal Physicians

Bellaire, Texas, 77401, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pain; Fever

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Temperature Changes

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

The original protocol required 50 subjects that completed 5 days of treatment. With protocol amendment 2, the criteria for enrollment/completion was reduced to 1 day of treatment. Subjects were required to have a minimum of 3 IV APAP doses per day.

Results Point of Contact

• Title: Lawrence Hill, VP Clinical Development
• Organization: Mallinckrodt Pharmaceuticals

lawrence.hill@mallinckrodt.com

908-238-6370

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2008
• First Posted: January 22, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: January 1, 2009
• Last Updated: May 10, 2017
• Results First Posted: January 6, 2011

Record last verified: 2017-04

Locations

US (14)