Safety and Pharmacokinetic (PK) Study of Intravenous (IV) Acetaminophen Administration in Pediatric Inpatients
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Tracking Information | |||||
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First Received Date ICMJE | June 27, 2007 | ||||
Last Updated Date | January 1, 2011 | ||||
Start Date ICMJE | June 2007 | ||||
Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
This is a PK study [ Time Frame: 48 hrs ] | ||||
Change History | Complete list of historical versions of study NCT00493246 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
This is a PK study [ Time Frame: 48 hrs ] | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Safety and Pharmacokinetic (PK) Study of Intravenous (IV) Acetaminophen Administration in Pediatric Inpatients | ||||
Official Title ICMJE | A Prospective, Multi-Center, Randomized, Open-Label, Single and Repeated Dose, 48 Hour Study, of Intravenous Acetaminophen in Pediatric Inpatients to Determine Pharmacokinetics (PK) and Safety in Acute Pain and Fever | ||||
Brief Summary | We are doing this study to find out what happens to acetaminophen in the body after it is given to children through the vein. Children's bodies may handle drugs differently than adults. Understanding how long the drug stays in the body and how the drug is changed or metabolized by the body (called pharmacokinetics) is an important step in learning what the best dose of acetaminophen for children should be. We are also interested in learning about the safety of this medication when given to children. |
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Detailed Description | A Prospective, Multi-Center, Randomized, Open-Label, Single and Repeated Dose, 48 Hour Study, of Intravenous Acetaminophen in Pediatric Inpatients to Determine Pharmacokinetics (PK) and Safety in Acute Pain and Fever |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: IV Acetaminophen
This study will investigate two doses (12.5 milligrams/kilogram (mg/kg) and 15 milligrams/kilogram) based on weight administered every four hours (q4h), every six hours (q6h), or every eight hours (q8h) (depending on age) Neonates: 12.5 mg/kg q6h IV acetaminophen Neonates: 15 mg/kg q8h IV acetaminophen Infants: 12.5 mg/kg q4h IV acetaminophen Infants: 15 mg/kg q6h IV acetaminophen Children: 12.5 mg/kg q4h IV acetaminophen Children: 15 mg/kg q6h IV acetaminophen Adolescents: 12.5 mg/kg q4h IV acetaminophen Adolescents: 15 mg/kg q6h IV acetaminophen Other Names:
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 75 | ||||
Completion Date | November 2008 | ||||
Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | To be eligible for entry into the Study, Subjects must meet or Subjects' Parent or Guardian must meet, agree with or confirm all of the following criteria:
Exclusion Criteria (Screening) A Subject is NOT eligible for entry if ANY of the following criteria are met:
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Gender | Both | ||||
Ages | up to 16 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00493246 | ||||
Other Study ID Numbers ICMJE | CPI-APA-102 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Mike Royal MD JD MBA, VP Clinical Develpment Analgesics, Cadence Pharmaceuticals | ||||
Study Sponsor ICMJE | Cadence Pharmaceuticals | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Cadence Pharmaceuticals | ||||
Verification Date | January 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |