A Multi-Center Study of the Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of IV Acetaminophen for the Treatment of Acute Pain in Pediatric Patients
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ClinicalTrials.gov Identifier: NCT01635101 |
Recruitment Status :
Completed
First Posted : July 6, 2012
Results First Posted : January 21, 2020
Last Update Posted : January 21, 2020
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Sponsor:
Mallinckrodt
Information provided by (Responsible Party):
Mallinckrodt
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Tracking Information | ||||
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First Submitted Date ICMJE | June 29, 2012 | |||
First Posted Date ICMJE | July 6, 2012 | |||
Results First Submitted Date ICMJE | September 10, 2019 | |||
Results First Posted Date ICMJE | January 21, 2020 | |||
Last Update Posted Date | January 21, 2020 | |||
Study Start Date ICMJE | June 2012 | |||
Actual Primary Completion Date | August 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Total Rescue Opioid Consumption [ Time Frame: in 24 hours ] Total micrograms per kilogram (µg/kg) of rescue opioid used during the same 24 hours the subject is on study medication
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Original Primary Outcome Measures ICMJE |
Total Rescue Opioid Consumption [ Time Frame: T0-T24; A total opiod consumption will be obtained from T0-T24. Total rescue opioid consumption will be collected during the 24 hours while the subject is on study medication. ] Total rescue opioid consumption from T0 to T24 (total milligrams (mg) per kilogram (kg) IV morphine equivalent), comparing each IV Acetaminophen Group to the combined Control Groups
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Multi-Center Study of the Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of IV Acetaminophen for the Treatment of Acute Pain in Pediatric Patients | |||
Official Title ICMJE | A Randomized, Placebo Controlled, Multi-Center Study of the Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of IV Acetaminophen for the Treatment of Acute Pain in Pediatric Patients | |||
Brief Summary | The purpose of this study is to demonstrate the efficacy and safety of Intravenous (IV) acetaminophen plus rescue opioids for the relief of moderate to severe acute pain in neonates and infants (age < 2 years) compared to placebo plus standard of care rescue opioids as well as characterize the concentration-effect relationship (PK/PD) of the intravenous acetaminophen as compared to the control group. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Acute Pain | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Hammer GB, Maxwell LG, Taicher BM, Visoiu M, Cooper DS, Szmuk P, Pheng LH, Gosselin NH, Lu J, Devarakonda K. Randomized Population Pharmacokinetic Analysis and Safety of Intravenous Acetaminophen for Acute Postoperative Pain in Neonates and Infants. J Clin Pharmacol. 2020 Jan;60(1):16-27. doi: 10.1002/jcph.1508. Epub 2019 Aug 25. | |||
* 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 | |||
Actual Enrollment ICMJE |
197 | |||
Original Estimated Enrollment ICMJE |
200 | |||
Actual Study Completion Date ICMJE | November 2015 | |||
Actual Primary Completion Date | August 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Pre-Randomization (Qualification) Inclusion Criteria Subject has not been administered any of the following:
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Sex/Gender ICMJE |
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Ages ICMJE | up to 2 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01635101 | |||
Other Study ID Numbers ICMJE | CPI-APA-353 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Responsible Party | Mallinckrodt | |||
Study Sponsor ICMJE | Mallinckrodt | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Mallinckrodt | |||
Verification Date | May 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |