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NCT01635101 · ClinicalTrials.gov registry record · Phase 3
A Multi-Center Study of the Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of IV Acetaminophen for the Treatment of Acute Pain in Pediatric Patients
A Phase 3 study, sponsored by Mallinckrodt.
- Completed
- Registry status
- Phase 3
- Development phase
- 197
- Enrollment target
NCT01635101: Completed Phase 3 study, sponsored by Mallinckrodt.
NCT01635101 is a Phase 3 study that has completed, run by Mallinckrodt. The registered enrollment target is 197 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01635101, a Phase 3 study, has completed, sponsored by Mallinckrodt.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 197 participants
- Enrollment target
Study 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.
Primary Outcome
Total micrograms per kilogram (µg/kg) of rescue opioid used during the same 24 hours the subject is on study medication
Interventions
- DRUG IV Acetaminophen
- DRUG IV Control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 197 participants |
| Start Date | 2012-06 |
| Est. Completion | 2015-11 |
| Phase | Phase 3 |
What the finished NCT01635101 record still lists
NCT01635101 is an interventional study that assigns participants to a tested intervention. The registered 197 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 2 interventions - of which IV Acetaminophen is the first listed.
NCT01635101 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01635101 about?
NCT01635101 is a clinical study titled "A Multi-Center Study of the Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of IV Acetaminophen for the Treatment of Acute Pain in Pediatric Patients". 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 conc...
What is the current status of trial NCT01635101?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 197 participants. The study started on 2012-06. Estimated completion is 2015-11.
What interventions are being tested in trial NCT01635101?
The interventions under investigation include: IV Acetaminophen (DRUG), IV Control (DRUG).
Who is sponsoring clinical trial NCT01635101?
This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01635101's enrollment target sits among peer trials
197 1390th of 2000 higher than 611 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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