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NCT02848729 · ClinicalTrials.gov registry record · Phase 4
Drug Interactions Between Morphine and Orally or IV Administered Acetaminophen
A Phase 4 study, sponsored by Mallinckrodt.
- Completed
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
NCT02848729: Completed Phase 4 study, sponsored by Mallinckrodt.
NCT02848729 is a Phase 4 study that has completed, run by Mallinckrodt. The registered enrollment target is 50 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02848729, a Phase 4 study, has completed, sponsored by Mallinckrodt.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
Study Summary
Morphine is the opioid used to treat pain after surgery. Acetaminophen (called APAP) can reduce the amount of opioids needed for this. The problem is that morphine slows down digestion. That can delay pain relief from APAP pills. It can even change what the body does to the drug \[pharmacokinetics (PK)\]. Some doctors have started using intravenous (IV) APAP with morphine, instead of the pills. This study will measure the PK of APAP pills and IV when used with morphine in healthy volunteers. IV APAP will likely be more effective and cause fewer side effects when used with morphine to treat pain after surgery.
Primary Outcome
The area under the plasma drug concentration-time curve (AUC) is an estimate of how much drug remains available for the body to use, within a certain amount of time after the drug is administered. AUC6 is reported for each of the 6-hour dosing periods of acetaminophen before (hours -6 to 0), during (hours 0-6 and 6-12) and after (hours 12-18) morphine co-administration for each route of acetaminophen administration
Interventions
- DRUG Saline
- DRUG Placebo Tablets
- DRUG IV Acetaminophen
- DRUG Oral Acetaminophen
- DRUG IV Morphine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2016-02 |
| Est. Completion | 2016-03 |
| Phase | Phase 4 |
What the finished NCT02848729 record still lists
NCT02848729 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 5 interventions - of which Saline is the first listed.
NCT02848729 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02848729 about?
NCT02848729 is a clinical study titled "Drug Interactions Between Morphine and Orally or IV Administered Acetaminophen". Morphine is the opioid used to treat pain after surgery. Acetaminophen (called APAP) can reduce the amount of opioids needed for this. The problem is that morphine slows down digestion. That can delay pain relief from APAP pills. It can even change what the body does to the drug \[pharmacokinetics ...
What is the current status of trial NCT02848729?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2016-02. Estimated completion is 2016-03.
What interventions are being tested in trial NCT02848729?
The interventions under investigation include: Saline (DRUG), Placebo Tablets (DRUG), IV Acetaminophen (DRUG), Oral Acetaminophen (DRUG), IV Morphine (DRUG).
Who is sponsoring clinical trial NCT02848729?
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 NCT02848729's enrollment target sits among peer trials
50 1255th of 2000 higher than 678 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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