Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients
This study has been completed.
Sponsor:
Cadence Pharmaceuticals
Information provided by:
Cadence Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00598702
First received: January 9, 2008
Last updated: January 10, 2011
Last verified: January 2011
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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:
|
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
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 | |
| Thomas Jefferson University | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| 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 Antipyretics Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013