A Multi-Center Study of the Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of IV Acetaminophen for the Treatment of Acute Pain in Pediatric Patients
Public ClinicalTrials.gov record NCT01635101. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT01635101
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Mallinckrodt
- Industry
- Enrollment
- 197 participants
Conditions and interventions
Conditions
Interventions
- IV Acetaminophen Drug
- IV Control Drug
Drug
Eligibility (public fields only)
- Age range
- 1 Day to 2 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2012
- Primary completion
- Jul 31, 2015
- Completion
- Oct 31, 2015
- Last update posted
- Jan 20, 2020
2012 – 2015
United States locations
- U.S. sites
- 22
- U.S. states
- 16
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Of Alabama | Birmingham | Alabama | 35294 | — |
| Children's Hospital of Orange County | Orange | California | 92868 | — |
| Rady Children's Hosptial San Diego | San Diego | California | 92123 | — |
| Stanford University | Stanford | California | 94305 | — |
| Jackson Memorial Hospital | Miami | Florida | 33236 | — |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | — |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Mott Children's Hospital | Ann Arbor | Michigan | 48109 | — |
| Amplatz Children's Hospital | Minneapolis | Minnesota | 55455 | — |
| Kings County Hospital Center | Brooklyn | New York | 11203 | — |
| University of North Carolina-Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Duke University | Durham | North Carolina | 27710 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | — |
| Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee | 37232 | — |
| Children's Medical Center Dallas | Dallas | Texas | 75235 | — |
| Univ. of Texas Health Sciences Center | Houston | Texas | 77030 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | — |
| Medical College of Wisconsin, Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01635101, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 20, 2020 · Synced Jun 25, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01635101 live on ClinicalTrials.gov.